Verona Pharma Announces the US FDA has Accepted the New Drug Application Filing for Ensifentrine for the Maintenance Treatment of COPD
11 9월 2023 - 3:00PM
Verona Pharma plc (Nasdaq: VRNA) (“Verona Pharma” or the
“Company”), announces the US Food and Drug Administration (“FDA”)
has accepted for review the Company’s New Drug Application (“NDA”)
seeking approval of ensifentrine for the maintenance treatment of
patients with chronic obstructive pulmonary disease (“COPD”). The
FDA has assigned a Prescription Drug User Fee Act (“PDUFA”) target
action date of June 26, 2024, and is not currently planning to hold
an advisory committee meeting to discuss the application.
“We are pleased with the FDA’s acceptance of our
NDA submission for ensifentrine for the maintenance treatment of
COPD and look forward to continuing to work with them during their
review,” said David Zaccardelli, Pharm. D., President and Chief
Executive Officer of Verona Pharma. “Hundreds of millions of people
around the world are suffering with COPD. Ensifentrine, if
approved, is expected to be the first novel mechanism available for
the maintenance treatment of COPD in more than 10 years. We believe
its bronchodilator and non-steroidal anti-inflammatory activity has
the potential to change the treatment paradigm. This NDA acceptance
brings us a step closer to our goal of delivering ensifentrine to a
broad population of patients suffering from COPD.”
The NDA included efficacy and safety data from
Verona Pharma’s Phase 3 ENHANCE trials, in which ensifentrine
demonstrated improvements in lung function and symptoms endpoints
and substantially reduced the rate and risk of COPD exacerbations.
Ensifentrine was well-tolerated in a broad population of subjects
with moderate to severe COPD.
For further information please contact:
Verona Pharma plc |
US Tel: +1-833-417-0262UK Tel: +44 (0)203 283 4200 |
Victoria Stewart, Senior Director of Investor Relations and
Communications |
IR@veronapharma.com |
Argot PartnersUS Investor Enquiries |
Tel: +1-212-600-1902verona@argotpartners.com |
Ten Bridge CommunicationsInternational / US Media
Enquiries |
Tel: +1-312-523-5016tbcverona@tenbridgecommunications.com |
Leslie Humbel |
|
About Verona Pharma
Verona Pharma is a clinical-stage
biopharmaceutical company focused on developing and commercializing
innovative therapies for the treatment of chronic respiratory
diseases with significant unmet medical needs. If successfully
developed and approved, Verona Pharma’s product candidate,
ensifentrine, has the potential to become the first non-steroidal
therapy for the treatment of respiratory diseases that combines
bronchodilator and anti-inflammatory activities in one molecule.
The Company has evaluated nebulized ensifentrine in its Phase 3
clinical program ENHANCE (“Ensifentrine as a Novel inHAled
Nebulized COPD thErapy”) for COPD maintenance treatment.
Ensifentrine met the primary endpoint in both ENHANCE-1 and
ENHANCE-2 trials demonstrating statistically significant and
clinically meaningful improvements in lung function. In addition,
ensifentrine substantially reduced the rate and risk of COPD
exacerbations in pooled analysis from ENHANCE-1 and ENHANCE-2. In
the third quarter of 2023, the US Food and Drug Administration
accepted for review the Company’s NDA for ensifentrine for the
maintenance treatment of patients with COPD and assigned a PDUFA
target action date of June 26, 2024. Two additional
formulations of ensifentrine have been evaluated in Phase 2 trials
for the treatment of COPD: dry powder inhaler (“DPI”) and
pressurized metered-dose inhaler (“pMDI”). Ensifentrine has
potential applications in cystic fibrosis, asthma and other
respiratory diseases. For more information, please visit
www.veronapharma.com.
Forward-Looking Statements
This press release contains forward-looking
statements. All statements contained in this press release that do
not relate to matters of historical fact should be considered
forward-looking statements, including, but not limited to,
statements relating to the timing of the FDA’s potential approval
of the NDA for ensifentrine by the PDUFA date of June 26, 2024, or
at any other time, statements regarding the potential for
ensifentrine to be the first novel mechanism available for the
maintenance treatment of COPD in over 10 years, the first therapy
for the treatment of respiratory diseases to combine bronchodilator
and non-steroidal anti-inflammatory activities in one molecule, and
the potential to change the treatment paradigm for COPD patients,
the potential of ensifentrine in the treatment of cystic fibrosis,
asthma and other respiratory diseases, and the potential of the DPI
and pMDI formulations of ensifentrine.
These forward-looking statements are based on
management's current expectations. These statements are neither
promises nor guarantees, but involve known and unknown risks,
uncertainties and other important factors that may cause our actual
results, performance or achievements to be materially different
from our expectations expressed or implied by the forward-looking
statements, including, but not limited to, the following: our
limited operating history; our need for additional funding to
complete development and commercialization of ensifentrine, which
may not be available and which may force us to delay, reduce or
eliminate our development or commercialization efforts; the
reliance of our business on the success of ensifentrine, our only
product candidate under development; economic, political,
regulatory and other risks involved with international operations;
the lengthy and expensive process of clinical drug development,
which has an uncertain outcome; serious adverse, undesirable or
unacceptable side effects associated with ensifentrine, which could
adversely affect our ability to develop or commercialize
ensifentrine; we may not be successful in developing ensifentrine
for multiple indications; our ability to obtain approval for and
commercialize ensifentrine in multiple major pharmaceutical
markets; misconduct or other improper activities by our employees,
consultants, principal investigators, third-party service providers
and licensees; our inability to realize the anticipated benefits
under licenses granted by us to third parties to develop and
commercialize ensifentrine, our future growth and ability to
compete depends on retaining our key personnel and recruiting
additional qualified personnel; material differences between our
“top-line” data and final data; our reliance on third parties,
including clinical research organizations, clinical investigators,
manufacturers and suppliers, and the risks related to these
parties’ ability to successfully develop and commercialize
ensifentrine; lawsuits related to patents covering ensifentrine and
the potential for our patents to be found invalid or unenforceable;
lawsuits related to our licensing of patents and know-how with
third parties for the development and commercialization of
ensifentrine; changes in our tax rates, unavailability of certain
tax credits or reliefs or exposure to additional tax liabilities or
assessments could affect our profitability, and audits by tax
authorities could result in additional tax payments for prior
periods; and our vulnerability to natural disasters, global
economic factors, geo-political actions and unexpected events,
including health epidemics or pandemics. These and other important
factors under the caption “Risk Factors” in our Annual Report on
Form 10-K for the year ended December 31, 2022, as updated in our
Quarterly Reports on Form 10-Q and our other reports filed with the
SEC, could cause actual results to differ materially from those
indicated by the forward-looking statements made in this press
release. Any such forward-looking statements represent management's
estimates as of the date of this press release. While we may elect
to update such forward-looking statements at some point in the
future, we disclaim any obligation to do so, even if subsequent
events cause our views to change. These forward-looking statements
should not be relied upon as representing our views as of any date
subsequent to the date of this press release.
Verona Pharma (NASDAQ:VRNA)
과거 데이터 주식 차트
부터 5월(5) 2024 으로 6월(6) 2024
Verona Pharma (NASDAQ:VRNA)
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부터 6월(6) 2023 으로 6월(6) 2024