Invivyd, Inc. (Nasdaq: IVVD), a biopharmaceutical company on a
mission to protect the vulnerable from serious viral infectious
diseases, today announced financial results for the full year ended
December 31, 2023 and recent business highlights.
“We made remarkable progress throughout 2023 and in recent
months. Roughly one year ago we were initiating the Phase 1
clinical trial of VYD222, and today we are incredibly proud to have
received emergency use authorization (EUA) of PEMGARDA for PrEP of
COVID-19 in certain adults and adolescents (aged 12 or older
weighing at least 40kg) in the U.S. with moderate-to-severe immune
compromise who are unlikely to mount an adequate response to
COVID-19 vaccination,” said Dave Hering, Chief Executive Officer of
Invivyd. “PEMGARDA is the first PrEP mAb to receive an EUA using a
rapid immunobridging trial design leveraging a biomarker as a
surrogate of clinical efficacy and the first authorized mAb from
our novel platform approach designed to rapidly and serially
engineer durable mAbs targeting conserved viral epitopes. This
exciting milestone is a testament to our team’s incredible
dedication, skill, and ability to execute to plan.”
Mr. Hering continued, “With PEMGARDA now authorized and
anticipated to be available for order in the U.S. imminently, we
are laser-focused on executing our commercial launch plan and look
forward to providing insights on key launch metrics as time
progresses. With a relatively compact field sales organization, we
believe that we can efficiently reach key healthcare practitioners
and institutions who care for the highest risk moderately to
severely immunocompromised adults and adolescents, with the
opportunity to potentially expand our efforts and footprint over
time within our authorized population.”
Recent Program Highlights
- PEMGARDA received EUA from
U.S. FDA: On March 22, 2024, PEMGARDA (pemivibart)
received EUA from the U.S. Food and Drug Administration (FDA) for
the pre-exposure prophylaxis (prevention) of COVID-19 in adults and
adolescents (12 years of age and older weighing at least 40
kg) who have moderate-to-severe immune compromise due to certain
medical conditions or receipt of certain immunosuppressive
medications or treatments and are unlikely to mount an adequate
response to COVID-19 vaccination. Recipients should not be
currently infected with or have had a known recent exposure to an
individual infected with SARS-CoV-2. The PEMGARDA EUA is based on
the totality of scientific evidence available, including data from
the company’s CANOPY clinical trial based on an immunobridging
approach. The company expects to have PEMGARDA available for order
in the U.S. imminently and is preparing for the full commercial
launch of PEMGARDA, with the deployment of the contracted field
sales force expected in the coming weeks.
- Leveraged INVYMAB™ platform
approach to design VYD2311, the company’s next anticipated
anti-SARS-CoV-2 mAb in a planned series of candidates: In
January 2024, Invivyd nominated VYD2311, a mAb optimized for
neutralization potency against recent SARS-CoV-2 lineages such as
BA.2.86 and JN.1, as a drug candidate. The company expects that
VYD2311 will be the next candidate that it advances into clinical
development. The company continues to engage with the FDA with the
aim of establishing a streamlined development pathway that would
allow the company to most efficiently leverage its INVYMAB platform
approach to serially generate new or modified mAbs to keep pace
with SARS-CoV-2 viral evolution.
Year End 2023 Financial Results
- Cash Position: Cash
and cash equivalents were $200.6 million as of December 31,
2023.
- Cash Runway: Based
on current operating plans and excluding anticipated cash
collections from PEMGARDA sales, Invivyd expects its existing total
cash and cash equivalents will enable the company to fund its
operating expenses and capital expenditure requirements into the
fourth quarter of 2024.
- Research & Development
(R&D) Expenses (including In-Process Research &
Development): R&D expenses were $163.6 million for the
year ended December 31, 2023, compared to $183.6 million for year
ended December 31, 2022. This decrease is primarily attributable to
a decrease in personnel-related costs in 2023 and to higher
clinical trial costs in 2022 due to ongoing adintrevimab clinical
trials, with no comparable costs during the same period in 2023 due
to the wind-down of adintrevimab clinical trials, partially offset
by an increase in commercial manufacturing costs of PEMGARDA and
ongoing clinical trial costs associated with our CANOPY clinical
trial in 2023.
- Selling, General &
Administrative (SG&A) Expenses: SG&A expenses were
$49.1 million for the year ended December 31, 2023, compared to
$47.0 million for the year ended December 31, 2022. This increase
is primarily attributable to an increase in personnel-related costs
and commercial costs, partially offset by a decrease in legal and
corporate governance costs.
- Net Loss and Net Loss
Share: Net loss was $198.6 million for the year ended
December 31, 2023, compared to $241.3 million for the year ended
December 31, 2022. Basic and diluted net loss per share was $1.81
for the year ended December 31, 2023, compared to $2.23 for the
year ended December 31, 2022.
About PEMGARDA
PEMGARDA (pemivibart) is a half-life extended investigational
monoclonal antibody (mAb). PEMGARDA was engineered from
adintrevimab, Invivyd’s investigational mAb that has a robust
safety data package and provided evidence of clinical efficacy in a
global Phase 2/3 clinical trial for the prevention of COVID-19.
PEMGARDA has demonstrated in vitro neutralizing activity in
pseudotyped virus-like particle and authentic virus neutralization
assays against major SARS-CoV-2 variants, including JN.1, the
dominant variant in the U.S. currently according to estimates from
the Centers for Disease Control and Prevention. PEMGARDA targets
the SARS-CoV-2 spike protein receptor binding domain (RBD), thereby
inhibiting virus attachment to the human ACE2 receptor on host
cells.
PEMGARDA (pemivibart) injection (4500 mg), for intravenous use
is an investigational mAb that has not been approved, but has been
authorized for emergency use by the U.S. FDA under an EUA for the
pre-exposure prophylaxis (prevention) of COVID-19 in adults and
adolescents (12 years of age and older weighing at least 40 kg) who
have moderate-to-severe immune compromise due to certain medical
conditions or receipt of certain immunosuppressive medications or
treatments and are unlikely to mount an adequate immune response to
COVID-19 vaccination. Recipients should not be currently infected
with or have had a known recent exposure to an individual infected
with SARS-CoV-2. PEMGARDA is not authorized for use for treatment
of COVID-19 or post-exposure prophylaxis of COVID-19. Anaphylaxis
has been observed with PEMGARDA and the PEMGARDA Fact Sheet for
Healthcare Providers includes a boxed warning for anaphylaxis. The
most common adverse events (all grades, incidence ≥2%) observed in
participants who have moderate-to-severe immune compromise treated
with PEMGARDA included systemic and local infusion-related or
hypersensitivity reactions, upper respiratory tract infection,
viral infection, influenza-like illness, fatigue, headache, and
nausea.
To support the EUA for PEMGARDA, an immunobridging approach was
used to determine if PEMGARDA may be effective for pre-exposure
prophylaxis of COVID-19. Immunobridging is based on the serum virus
neutralizing titer-efficacy relationships identified with other
neutralizing human mAbs against SARS-CoV-2. This includes
adintrevimab, the parent mAb of pemivibart, and other mAbs that
were previously authorized for EUA. There are limitations of the
data supporting the benefits of PEMGARDA. Evidence of clinical
efficacy for other neutralizing human mAbs against SARS-CoV-2 was
based on different populations and SARS-CoV-2 variants that are no
longer circulating. Additionally, the variability associated with
cell-based EC50 value determinations, along with limitations
related to pharmacokinetic data and efficacy estimates for the mAbs
in prior clinical trials, impact the ability to precisely estimate
protective titer ranges.
The emergency use of PEMGARDA is only authorized for the
duration of the declaration that circumstances exist justifying the
authorization of the emergency use of drugs and biological products
during the COVID-19 pandemic under Section 564(b)(1) of the Federal
Food, Drug, and Cosmetic Act, 21 U.S.C. § 360bbb-3(b)(1), unless
the declaration is terminated or authorization revoked sooner.
About Invivyd
Invivyd, Inc. (Nasdaq: IVVD) is commercial-stage company on a
mission to rapidly and perpetually deliver antibody-based therapies
that protect vulnerable people from the devastating consequences of
circulating viral threats, beginning with SARS-CoV-2. The company’s
proprietary INVYMAB™ platform approach combines state-of-the-art
viral surveillance and predictive modeling with advanced antibody
engineering. INVYMAB is designed to facilitate the rapid, serial
generation of new monoclonal antibodies (mAbs) to keep pace with
evolving viral threats. In March 2024, Invivyd received emergency
use authorization (EUA) from the U.S. FDA for its first mAb in a
planned series of innovative antibody candidates. Visit
https://invivyd.com/ to learn more.
Cautionary Note Regarding Forward Looking
Statements
This press release contains forward-looking statements within
the meaning of the Private Securities Litigation Reform Act of
1995. Words such as “anticipates,” “believes,” “could,” “expects,”
“intends,” “potential,” “projects,” and “future” or similar
expressions (as well as other words or expressions referencing
future events, conditions or circumstances) are intended to
identify forward-looking statements. Forward-looking statements
include statements concerning, among other things, the potential of
PEMGARDA as a mAb for pre-exposure prophylaxis (prevention) of
COVID-19 in certain adults and adolescents with moderate-to-severe
immune compromise; the company’s plans related to the
commercialization of PEMGARDA, including its expectations regarding
availability and supply of PEMGARDA, as well as the company’s plans
to provide insights on key launch metrics as time progresses; the
ability of the company’s INVYMAB platform approach to rapidly and
serially engineer durable mAbs targeting conserved epitopes; the
company’s ongoing research and clinical development efforts, and
the timing thereof; the company’s expectation that PEMGARDA is the
first mAb in a planned series of innovative antibody candidates and
VYD2311 will be the next mAb candidate to enter clinical
development; the company’s expectations to engage with the FDA with
the aim of establishing a streamlined development pathway that
would allow the company to most efficiently leverage its INVYMAB
platform approach to serially generate new or modified mAbs to keep
pace with SARS-CoV-2 viral evolution; the future of the COVID-19
landscape, particularly for vulnerable populations; the company’s
expectations regarding the anticipated timeline of its cash runway;
the company’s mission to rapidly and perpetually deliver
antibody-based therapies that protect vulnerable people from the
devastating consequences of circulating viral threats, beginning
with SARS-CoV-2; and other statements that are not historical fact.
The company may not actually achieve the plans, intentions or
expectations disclosed in the company’s forward-looking statements
and you should not place undue reliance on the company’s
forward-looking statements. These forward-looking statements
involve risks and uncertainties that could cause the company’s
actual results to differ materially from the results described in
or implied by the forward-looking statements, including, without
limitation: how long the EUA granted by the FDA for PEMGARDA will
remain in effect and whether the EUA is revoked or revised by the
FDA; the company’s ability to build and maintain sales, marketing
and distribution capabilities to successfully commercialize
PEMGARDA; changes in expected or existing competition; the timing
and progress of the company’s discovery, preclinical and clinical
development activities; the outcome of the company’s engagement
with the FDA on a potential streamlined development pathway; the
uncertainties and timing of the regulatory authorization or
approval process, and available development and regulatory pathways
for authorization or approval of the company’s product candidates;
changes in the regulatory environment; unexpected safety or
efficacy data observed during preclinical studies or clinical
trials; the ability to maintain a continued acceptable safety,
tolerability and efficacy profile of PEMGARDA or any other product
candidate following regulatory authorization or approval; the
predictability of clinical success of the company’s product
candidates based on neutralizing activity in preclinical studies;
the risk that results of preclinical studies or clinical trials may
not be predictive of future results, and interim data are subject
to further analysis; the company’s reliance on third parties with
respect to virus assay creation and product candidate testing and
with respect to its clinical trials; variability of results in
models used to predict activity against SARS-CoV-2 variants;
whether PEMGARDA or any other product candidate is able to
demonstrate and sustain neutralizing activity against major
SARS-CoV-2 variants, particularly in the face of viral evolution;
the complexities of manufacturing mAb therapies; the company’s
dependence on third parties to manufacture, label, package, store
and distribute clinical and commercial supplies of its product
candidates; whether the company is able to provide sufficient
commercial supply of PEMGARDA to meet market demand; whether the
company can obtain and maintain third-party coverage and adequate
reimbursement for PEMGARDA or any other product candidate; the
company’s ability to leverage its INVYMAB platform approach to
rapidly and serially generate durable mAbs that keep pace with
SARS-CoV-2 viral evolution or other viral threats; any litigation
and other proceedings or government investigations relating to the
company; the company’s ability to continue as a going concern; and
whether the company has adequate funding to meet future operating
expenses and capital expenditure requirements. Other factors that
may cause the company’s actual results to differ materially from
those expressed or implied in the forward-looking statements in
this press release are described under the heading “Risk Factors”
in the company’s Annual Report on Form 10-K for the year ended
December 31, 2022 filed with the Securities and Exchange Commission
(SEC), and in the company’s other filings with the SEC, and in its
future reports to be filed with the SEC and available at
www.sec.gov. Forward-looking statements contained in this press
release are made as of this date, and Invivyd undertakes no duty to
update such information whether as a result of new information,
future events or otherwise, except as required under applicable
law.
This press release contains hyperlinks to information that is
not deemed to be incorporated by reference in this press
release.
INVIVYD,
INC.CONSOLIDATED BALANCE
SHEETS(UNAUDITED)(In thousands,
except share and per share amounts)
|
|
December 31,2023 |
|
|
December 31,2022 |
|
Assets |
|
|
|
|
|
|
Current assets: |
|
|
|
|
|
|
Cash and cash equivalents |
|
$ |
200,641 |
|
|
$ |
92,076 |
|
Marketable securities |
|
|
— |
|
|
|
279,915 |
|
Prepaid expenses and other current assets |
|
|
24,240 |
|
|
|
4,926 |
|
Total current assets |
|
|
224,881 |
|
|
|
376,917 |
|
Property and equipment, net |
|
|
1,896 |
|
|
|
2,282 |
|
Operating lease right-of-use
assets |
|
|
2,229 |
|
|
|
3,777 |
|
Other non-current assets |
|
|
175 |
|
|
|
191 |
|
Total assets |
|
$ |
229,181 |
|
|
$ |
383,167 |
|
Liabilities, Preferred
Stock and Stockholders’ Equity |
|
|
|
|
|
|
Current liabilities: |
|
|
|
|
|
|
Accounts payable |
|
$ |
7,953 |
|
|
$ |
1,517 |
|
Accrued expenses |
|
|
40,860 |
|
|
|
21,911 |
|
Operating lease liabilities, current |
|
|
1,443 |
|
|
|
1,559 |
|
Other current liability |
|
|
35 |
|
|
|
44 |
|
Total current liabilities |
|
|
50,291 |
|
|
|
25,031 |
|
Operating lease liabilities,
non-current |
|
|
722 |
|
|
|
2,165 |
|
Other non-current liability |
|
|
700 |
|
|
|
— |
|
Early-exercise liability |
|
|
— |
|
|
|
1 |
|
Total liabilities |
|
|
51,713 |
|
|
|
27,197 |
|
Commitments and
contingencies |
|
|
|
|
|
|
Stockholders’ equity
(deficit): |
|
|
|
|
|
|
Preferred stock (undesignated),
$0.0001 par value; 10,000,000 shares authorized and no shares
issued and outstanding at December 31, 2023 and December 31,
2022 |
|
|
— |
|
|
|
— |
|
Common stock, $0.0001 par value;
1,000,000,000 shares authorized, 110,160,684 shares issued and
outstanding at December 31, 2023; 109,044,046 shares issued and
outstanding at December 31, 2022 |
|
|
11 |
|
|
|
11 |
|
Additional paid-in capital |
|
|
909,539 |
|
|
|
889,657 |
|
Accumulated other comprehensive
loss |
|
|
(13 |
) |
|
|
(272 |
) |
Accumulated deficit |
|
|
(732,069 |
) |
|
|
(533,426 |
) |
Total stockholders’ equity |
|
|
177,468 |
|
|
|
355,970 |
|
Total liabilities, preferred stock and stockholders’ equity |
|
$ |
229,181 |
|
|
$ |
383,167 |
|
INVIVYD,
INC.CONSOLIDATED STATEMENTS OF OPERATIONS AND
COMPREHENSIVE LOSS(UNAUDITED)(In
thousands, except share and per share amounts)
|
|
Year Ended December 31, |
|
|
|
2023 |
|
|
2022 |
|
Operating expenses: |
|
|
|
|
|
|
Research and development(1) |
|
$ |
158,658 |
|
|
$ |
179,214 |
|
Acquired in-process research and development(2) |
|
|
4,975 |
|
|
|
4,400 |
|
Selling, general and administrative |
|
|
49,125 |
|
|
|
47,044 |
|
Warrant expense(3) |
|
|
— |
|
|
|
17,373 |
|
Total operating expenses |
|
|
212,758 |
|
|
|
248,031 |
|
Loss from operations |
|
|
(212,758 |
) |
|
|
(248,031 |
) |
Other income: |
|
|
|
|
|
|
Other income, net |
|
|
14,115 |
|
|
|
6,714 |
|
Total other income, net |
|
|
14,115 |
|
|
|
6,714 |
|
Net loss |
|
|
(198,643 |
) |
|
|
(241,317 |
) |
Other comprehensive income
(loss) |
|
|
|
|
|
|
Unrealized gain (loss) on available-for-sale securities, net of
tax |
|
|
259 |
|
|
|
(264 |
) |
Comprehensive loss |
|
$ |
(198,384 |
) |
|
$ |
(241,581 |
) |
Net loss per share attributable
to common stockholders, basic and diluted |
|
$ |
(1.81 |
) |
|
$ |
(2.23 |
) |
Weighted-average common shares
outstanding, basic and diluted |
|
|
109,526,053 |
|
|
|
108,268,289 |
|
(1) |
|
Includes
related-party amounts of $8,418 and $8,154 for the years ended
December 31, 2023 and 2022, respectively. |
(2) |
|
Includes related-party amounts of $4,975 and $4,400 for the
years ended December 31, 2023 and 2022, respectively. |
(3) |
|
Includes related-party amounts of $0 and $17,373 for the years
ended December 31, 2023 and 2022, respectively. |
|
|
|
IMPORTANT SAFETY INFORMATION
WARNING: ANAPHYLAXIS
- Anaphylaxis has been observed
with PEMGARDA in 0.6% (4/623) of participants in a
clinical trial.
- Anaphylaxis was reported during the first and
second infusion of PEMGARDA.
- Anaphylaxis can be life-threatening.
- Prior to administering PEMGARDA, consider the potential
benefit of COVID-19 prevention along with the risk of
anaphylaxis.
- Administer PEMGARDA only in settings in which
healthcare providers have immediate access to medications to
treat anaphylaxis and the ability to activate the emergency medical
system (EMS), as necessary.
- Clinically monitor individuals during the infusion and
for at least two hours after completion of
the infusion.
- Discontinue PEMGARDA immediately if signs or
symptoms of anaphylaxis or any severe systemic reaction are
observed and initiate appropriate medications and/or supportive
therapy.
CONTRAINDICATIONS
PEMGARDA is contraindicated in individuals with previous severe
hypersensitivity reactions, including anaphylaxis, to any component
of PEMGARDA.
WARNINGS AND PRECAUTIONS
Hypersensitivity Including Anaphylaxis and
Infusion-Related ReactionsSerious hypersensitivity
reactions, including anaphylaxis, have been observed with PEMGARDA.
If signs and symptoms of a clinically significant hypersensitivity
reaction or anaphylaxis occur, immediately discontinue
administration, and initiate appropriate medications and/or
supportive therapy. Clinically monitor individuals during the
60-minute infusion and for at least two hours after completion of
the infusion.
Risk of Cross-Hypersensitivity
With COVID-19 VaccinesPEMGARDA contains
polysorbate 80, which is in some COVID-19 vaccines and is
structurally similar to polyethylene glycol (PEG), an ingredient in
other COVID-19 vaccines. For individuals with a history of severe
hypersensitivity reaction to a COVID-19 vaccine, consider
consultation with an allergist-immunologist prior to PEMGARDA
administration.
Risk for COVID-19 Due to SARS-CoV-2 Viral Variants Not
Neutralized by PEMGARDACertain SARS-CoV-2 viral variants
may emerge that are not neutralized by monoclonal antibodies such
as PEMGARDA. PEMGARDA may not be effective at preventing COVID-19
caused by these SARS-CoV-2 viral variants. Inform individuals of
the increased risk, compared to other variants, for COVID-19 due to
emergent SARS-CoV-2 viral variants not neutralized by PEMGARDA. If
signs or symptoms of COVID-19 occur, advise individuals to test for
COVID-19 and seek medical attention, including starting treatment
for COVID-19 as appropriate.
ADVERSE REACTIONSThe most common adverse events
(all grades, incidence ≥2%) observed in participants who have
moderate-to-severe immune compromise treated with PEMGARDA included
systemic and local infusion-related or hypersensitivity reactions,
upper respiratory tract infection, viral infection, influenza-like
illness, fatigue, headache, and nausea.
USE IN SPECIFIC POPULATIONS
PregnancyThere are insufficient data to
evaluate a drug-associated risk of major birth defects,
miscarriage, or adverse maternal or fetal outcomes. PEMGARDA should
only be used during pregnancy if the potential benefit outweighs
the potential risk for the mother and the fetus.
LactationThere are no available data on the
presence of PEMGARDA in human or animal milk, the effects on the
breastfed infant, or the effects on milk production. Maternal IgG
is known to be present in human milk. The developmental and health
benefits of breastfeeding should be considered along with the
mother’s clinical need for PEMGARDA and any potential adverse
effects on the breastfed infant from PEMGARDA.
Pediatric UsePEMGARDA is not authorized for use
in pediatrics less than 12 years of age or weighing less than 40
kg. The safety and effectiveness of PEMGARDA has not been
established in pediatrics.
EMERGENCY USE AUTHORIZATION (EUA) FOR
PEMGARDA
The U.S. Food and Drug Administration (FDA) has issued an EUA
for the emergency use of the unapproved product PEMGARDA for the
pre-exposure prophylaxis of COVID-19 in adults and adolescents (12
years of age and older weighing at least 40 kg):
- Who are not currently infected with SARS-CoV-2 and who have not
had a known recent exposure to an individual infected with
SARS-CoV-2 and
- Who have moderate-to-severe immune compromise due to a medical
condition or receipt of immunosuppressive medications or treatments
and are unlikely to mount an adequate response to
COVID-19 vaccination.
LIMITATIONS OF AUTHORIZED USE
- PEMGARDA is not authorized for use:
- For treatment of COVID-19, or
- For post-exposure prophylaxis of COVID-19 in individuals who
have been exposed to someone infected with SARS-CoV-2.
- Pre-exposure prophylaxis with PEMGARDA is not a substitute for
vaccination in individuals for whom COVID-19 vaccination is
recommended. Individuals for whom COVID-19 vaccination is
recommended, including individuals with moderate-to-severe immune
compromise who may derive benefit from COVID-19 vaccination, should
receive COVID-19 vaccination.
- In individuals who have recently received a COVID-19 vaccine,
PEMGARDA should be administered at least 2 weeks after
vaccination.
PEMGARDA may only be prescribed for an individual patient by
physicians, advanced practice registered nurses, and physician
assistants that are licensed or authorized under State law to
prescribe drugs.
PEMGARDA has been authorized by FDA for the emergency use
described above.
PEMGARDA is not FDA-approved for any use, including use for
pre-exposure prophylaxis of COVID-19.
PEMGARDA is authorized only for the duration of the declaration
that circumstances exist justifying the authorization of the
emergency use of PEMGARDA under Section 564(b)(1) of the Federal
Food Drug, and Cosmetic Act, 21 U.S.C. § 360bbb 3(b)(1),
unless the authorization is terminated or revoked sooner.
See full Fact Sheet for Healthcare Providers, Including
Boxed Warning and Fact Sheet for Patients,
Parents, and Caregivers for examples of medical conditions
or treatments that may result in moderate to severe immune
compromise and an inadequate immune response to COVID-19
vaccination, the justification for emergency use of drugs during
the COVID-19 pandemic, information on available alternatives, and
additional information on COVID-19. The FDA Letter of
Authorization is also available for reference.
The prescribing healthcare provider and/or the provider’s
designee is/are responsible for mandatory reporting of all serious
adverse events* and medication errors potentially related to
PEMGARDA within 7 calendar days from the healthcare provider’s
awareness of the event, using FDA Form 3500 (for information on how
to access this form, see below). The FDA requires that such
reports, using FDA Form 3500, include the following:
- Patient demographics and baseline characteristics (e.g.,
patient identifier, age or date of birth, sex, weight, ethnicity,
and race).
- A statement “PEMGARDA use for the pre-exposure prophylaxis of
COVID-19 under Emergency Use Authorization (EUA)” under the
“Describe Event, Problem, or Product Use/Medication
Error” heading.
- Information about the serious adverse event or medication error
(e.g., signs and symptoms, test/laboratory data, complications,
timing of drug initiation in relation to the occurrence of the
event, duration of the event, treatment required to mitigate the
event, evidence of event improvement/disappearance after stopping
or reducing the dosage, evidence of event reappearance after
reintroduction, clinical outcomes).
- Patient’s preexisting medical conditions and use of concomitant
products.
- Information about the product (e.g., dosage, route of
administration, NDC #).
Submit serious adverse event and medication error reports using
FDA Form 3500 to FDA MedWatch using one of the following
methods:
- Complete and submit the report online:
www.fda.gov/medwatch/report.htm.
- Complete and submit a postage-paid FDA Form 3500
(https://www.fda.gov/media/76299/download) and return by:
- Mail to MedWatch, 5600 Fishers Lane, Rockville, MD 20852-9787,
or
- Fax to 1-800-FDA (332)-0178, or
- Call 1-800-FDA (332)-1088 to request a reporting form.
In addition, please provide a copy of all FDA MedWatch forms
to:
Invivyd, Inc.Email: pv@invivyd.comOr
call Invivyd, Inc. at 1-800-890-3385 to report serious adverse
events.
The prescribing healthcare provider and/or the provider’s
designee is/are responsible for mandatory responses to requests
from FDA for information about serious adverse events and
medication errors following receipt of PEMGARDA.
*Serious adverse events are defined as:
- Death
- A life-threatening adverse event
- Inpatient hospitalization or prolongation of existing
hospitalization
- A persistent or significant incapacity or substantial
disruption of the ability to conduct normal life functions
- A congenital anomaly/birth defect
- Other important medical events, which may require a medical or
surgical intervention to prevent death, a life-threatening event,
hospitalization, disability, or congenital anomaly
You may report side effects related to Invivyd, Inc. products by
sending an email to medinfo@invivyd.com.
Contacts:
Scott Young(781) 208-1747syoung@invivyd.com
Gabriella Linville-Engler(781)
208-0160gengler@invivyd.com
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