- TAKHZYRO Solution for Injection in 2 mL Pre-Filled Pen is
Now Approved to Facilitate Subcutaneous Administration in
Adolescent (Aged 12 Years and Above) and Adult Patients with
HAE.1
- The Pre-Filled Pen Option is Designed to Allow for An
Individualized Treatment Approach for Adolescent and Adult HAE
Patients.
- In the EU, TAKHZYRO is Approved for Routine
Prevention of Recurrent HAE Attacks in Patients Aged 2 Years and
Older.1
ZURICH, Feb. 24,
2025 /PRNewswire/ -- Takeda (TSE: 4502) (NYSE: TAK)
announced today that the EMA has approved an additional 2 mL
pre-filled pen option for TAKHZYRO® (lanadelumab) for
subcutaneous administration in adolescents (aged 12 years and
above) and adult patients with Hereditary Angioedema
(HAE).1
The additional subcutaneous administration option expands
Takeda's offering in this space, showing dedication to the HAE
community while providing individualized treatment options to
support patients with a life-threatening disease, by helping to
reduce HAE burden and improving their Quality of Life.
"HAE affects an estimated 1 in 50,000 people worldwide and is
often under recognised, under diagnosed and under
treated.3 We welcome the swift approval by the EMA
on this additional subcutaneous administration option," said
Irmgard Andresen, Global Medical
Lead HAE at Takeda. "HAE patients 12 years and older now have an
additional individualized treatment option available to them."
TAKHZYRO® (lanadelumab) is currently approved as 150
mg solution for injection in pre-filled syringe, 300 mg solution
for injection in pre-filled syringe, and 300 mg solution for
injection in vial.1 This approval for an additional
subcutaneous administration option, TAKHZYRO® 300 mg
solution for injection in pre-filled pen, containing 300 mg of
lanadelumab in 2 mL of solution, was supported by a clinical
study.2
Takeda is dedicated to providing innovative treatment options to
support patients, particularly those from underserved communities,
and continues its leadership in HAE treatment, supported by a
noteworthy data pool from historical engagement in this area.
Notes to editors:
About HAE
Hereditary angioedema (HAE) is a rare genetic disorder that
results in recurring attacks of oedema – swelling – in various
parts of the body, including the abdomen, face, feet, genitals,
hands and throat. The swelling can be debilitating and
painful.4 Attacks that obstruct the airways can cause
asphyxiation and are potentially life threatening.5 HAE
affects an estimated 1 in 50,000 people worldwide.3 It
is often under recognised, under diagnosed and under
treated.3
HAE, like so many other rare diseases, is highly complex, and
patients, their families and caregivers often undergo years of
strain trying to understand their disease, get a definitive
diagnosis and gain access to the medicines they need. At Takeda we
are a committed champion for the patients we serve. Every
individual living with HAE is unique and by listening and reacting
to their needs, we translate the insights we gain into innovative
solutions – from diagnosis to ongoing management. Advancing the
science is crucial to the way we operate and we are bold in our
mission to accelerate diagnosis and develop treatments that will
make a difference to the lives of HAE patients, their support
networks and those medical professionals who care for them.
About Lanadelumab (TAKHZYRO®)1
Lanadelumab is a fully human monoclonal antibody that
specifically binds and decreases plasma kallikrein and is indicated
for routine prevention of recurrent attacks of HAE in patients aged
2 years and older.1 It was studied in one of the largest
prevention studies in HAE with the longest active treatment
duration, and Lanadelumab consistently demonstrated HAE attack
reduction. Lanadelumab is formulated for subcutaneous
administration and has a half-life of approximately two
weeks.1 Lanadelumab is intended for self-administration
or administration by a caregiver once trained by a healthcare
professional.1
|
Product Name
|
TAKHZYRO 150 mg
solution for injection in pre-filled syringe; TAKHZYRO 300 mg
solution for injection in pre-filled syringe; TAKHZYRO 300 mg
solution for injection in pre-filled pen; TAKHZYRO 300 mg solution
for injection
|
|
Generic Name
|
Lanadelumab
|
|
Indication
|
TAKHZYRO is indicated
for routine prevention of recurrent attacks of hereditary
angioedema (HAE) in patients aged 2 years and older.
|
|
Posology and
Administration
|
This medicinal product
should be initiated under the supervision of a physician
experienced in the management of patients with hereditary
angioedema (HAE).
Adults and Adolescents 12 to less than 18 years of age
The recommended
starting dose is 300 mg lanadelumab every 2 weeks. In patients who
are stably attack free on treatment, a dose reduction to 300 mg
lanadelumab every 4 weeks may be considered, especially in patients
with low weight.
In patients with a body
weight less than 40 kg, a starting dose of 150 mg lanadelumab every
2 weeks may also be considered. In patients who are stably attack
free on treatment, a dose reduction to 150 mg lanadelumab every 4
weeks may be considered.
Children 2 to less than
12 years of age
The recommended dose of
lanadelumab for children 2 to less than 12 years of age is based on
body weight (see table below) and should only be administered via a
pre-filled syringe or vial.
The pre-filled pen has
not been studied in children 2 to less than 12 years of age and
therefore should not be used.
|
About Takeda
Takeda is focused on creating better health for people and a
brighter future for the world. We aim to discover and deliver
life-transforming treatments in our core therapeutic and business
areas, including gastrointestinal and inflammation, rare diseases,
plasma-derived therapies, oncology, neuroscience and vaccines.
Together with our partners, we aim to improve the patient
experience and advance a new frontier of treatment options through
our dynamic and diverse pipeline. As a leading values-based,
R&D-driven biopharmaceutical company headquartered in
Japan, we are guided by our
commitment to patients, our people and the planet. Our employees in
approximately 80 countries and regions are driven by our purpose
and are grounded in the values that have defined us for more than
two centuries. For more information, visit www.takeda.com.
Guidance for use
TAKHZYRO treatment should be initiated under the supervision of
a physician experienced in the management of patients with
hereditary angioedema (HAE). For adults and adolescents (12 to less
than 18 years of age), TAKHZYRO may be self-administered or
administered by a caregiver only after training on subcutaneous
injection technique by a healthcare professional. For children (2
to less than 12 years of age), TAKHZYRO should only be administered
by a caregiver after training on SC subcutaneous injection
technique by a healthcare professional.
Contraindication
Hypersensitivity to the active substance or to any of the
excipients.
Hypersensitivity reactions have been observed. In case of a
severe hypersensitivity reaction, administration of TAKHZYRO must
be stopped immediately and appropriate treatment must be
initiated.
The most commonly observed adverse reaction (52.4%)
associated with TAKHZYRO was injection site reactions (ISR)
including injection site pain, injection site erythema and
injection site bruising. Of these ISRs, 97% were of mild intensity,
90% resolved within 1 day after onset with a median duration of 6
minutes.
Hypersensitivity reaction (mild and moderate pruritus,
discomfort and tingling of tongue) was observed (1.2%)
Very common adverse reactions (frequency ≥1/10) were
injection site reactions including: pain, erythema, bruising,
discomfort, haematoma, haemorrhage, pruritus, swelling, induration,
paraesthesia, reaction, warmth, oedema and rash.
Please consult the EMA TAKHZYRO® Summary of
Product Characteristics before prescribing.1
Important Notice
For the purposes of this notice, "press release" means this
document, any oral presentation, any question-and-answer session
and any written or oral material discussed or distributed by Takeda
Pharmaceutical Company Limited ("Takeda") regarding this release.
This press release (including any oral briefings and any
question-and-answer in connection with it) is not intended to, and
does not constitute, represent or form part of any offer,
invitation or solicitation of any offer to purchase, otherwise
acquire, subscribe for, exchange, sell or otherwise dispose of, any
securities or the solicitation of any vote or approval in any
jurisdiction.
1 https://www.ema.europa.eu/en/medicines/human/EPAR/takhzyro.
Relevant documents to be published here as soon as publicly
available.
2 https://www.clinicaltrials.gov/study/NCT03918239?intr=NCT03918239&rank=1#more-information.
Last accessed: February 2025.
3 Longhurst, H. J., & Bork, K. (2019).
Hereditary angioedema: an update on causes, manifestations and
treatment. British Journal of Hospital Medicine, 80(7),
391-398.
4 Maurer, M., et al. (2022). The international
WAO/EAACI guideline for the management of hereditary angioedema—The
2021 revision and update. Allergy, 77(7), 1961–1990.
https://doi.org/10.1111/all.15214.
5 Banerji, A., Davis, K. H., Brown, T. M.,
Hollis, K., Hunter, S. M., Long, J., ... & Devercelli, G.
(2020). Patient-reported burden of hereditary angioedema: findings
from a patient survey in the United States. Annals of Allergy,
Asthma & Immunology, 124(6), 600-607.
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