Bavarian Nordic Announces FDA Acceptance and Priority Review of the BLA for its Chikungunya Vaccine
13 Agosto 2024 - 7:44PM
UK Regulatory
Bavarian Nordic Announces FDA Acceptance and Priority Review of the
BLA for its Chikungunya Vaccine
- PDUFA target action date of February 14, 2025
COPENHAGEN, Denmark, August 13,
2024 – Bavarian Nordic A/S (OMX: BAVA) today announced
that the U.S. Food and Drug Administration (FDA) has accepted and
granted Priority Review for the Biologics License Application (BLA)
for CHIKV VLP, the Company’s vaccine candidate for immunization to
prevent disease caused by chikungunya virus infection in
individuals 12 years of age and older.
The Priority Review designation means the FDA is
targeting completion of its review within six months, compared to
10 months under standard review, and thus has assigned a
Prescription Drug User Free Act (PDUFA) target action date of
February 14, 2025.
“We are encouraged by the FDA’s decision to
grant Priority Review to our chikungunya vaccine, allowing for a
shorter review time, and we look forward to working closely with
the regulators to make our vaccine available to individuals 12
years of age and older at risk of chikungunya virus infection. The
FDA review, along with the ongoing review of our CHIKV VLP vaccine
by EMA, represent the first regulatory reviews of a chikungunya
vaccine for adolescents, potentially providing a broader usage by
populations at risk of this debilitating disease,” said
Paul Chaplin, President and CEO of Bavarian
Nordic.
CHIKV VLP is currently also under accelerated
assessment review with the European Medicines Agency (EMA),
potentially supporting approval of the vaccine by the European
Commission in the first half of 2025.
About CHIKV VLP vaccine
CHIKV VLP is an adjuvanted VLP-based vaccine candidate for active
immunization to prevent disease caused by CHIKV infection. Pending
regulatory approval, the single-dose vaccine will be made in a
pre-filled syringe, designed to ease administration by saving
vaccinators' time and reducing the risk of administrative
errors.
The CHIKV VLP vaccine candidate received
Breakthrough Therapy designation and Fast Track designation from
the FDA in October 2020 and April 2018, respectively, and PRIME
designation from the EMA in September 2019. These designations are
designed to facilitate the development or expedite review of
medicines that either target an unmet medical need or may
demonstrate substantial improvement over available therapy. In
February 2024, the Committee for Medicinal Products for Human Use
(CHMP) under EMA granted accelerated assessment for the MAA for the
CHIKV VLP vaccine candidate based on the vaccine’s major interest
for public health and therapeutic innovation.
About chikungunya
Chikungunya is a mosquito-borne viral disease caused by the
chikungunya virus (CHIKV), which belongs to the group of
arboviruses like dengue virus. CHIKV disease typically presents
with acute symptoms, including fever, rash, fatigue, headache, and
often severe and incapacitating joint pain. While mortality is
relatively low, morbidity is high; nearly 50% of individuals with
CHIKV disease have debilitating long-term symptoms that can
intensify with age. In the past 20 years, the CHIKV has emerged in
several previously non-endemic regions in Asia, Africa, southern
Europe, and the Americas, often causing large unpredictable
outbreaks. Recent data1 suggest that chikungunya is
severely underreported and often misdiagnosed as dengue fever due
to lack of proper testing.
About Bavarian Nordic
Bavarian Nordic is a fully integrated vaccine company with a
mission to protect and save lives through innovative vaccines. We
are a global leader in smallpox and mpox vaccines, supplied to
governments to enhance public health preparedness and have a strong
portfolio of vaccines for travelers and endemic diseases. For more
information visit www.bavarian-nordic.com.
Forward-looking statements
This announcement includes forward-looking statements that involve
risks, uncertainties and other factors, many of which are outside
of our control, that could cause actual results to differ
materially from the results discussed in the forward-looking
statements. Forward-looking statements include statements
concerning our plans, objectives, goals, future events, performance
and/or other information that is not historical information. All
such forward-looking statements are expressly qualified by these
cautionary statements and any other cautionary statements which may
accompany the forward-looking statements. We undertake no
obligation to publicly update or revise forward-looking statements
to reflect subsequent events or circumstances after the date made,
except as required by law.
Contacts
Europe: Rolf Sass Sørensen, Vice President Investor Relations,
rss@bavarian-nordic.com, Tel: +45 61 77 47 43
US: Graham Morrell, Paddock Circle Advisors,
graham@paddockcircle.com, Tel: +1 781 686 9600
Company Announcement no. 22 / 2024
1 Ribas Freitas AR, Pinheiro Chagas
AA, Siqueira AM, Pamplona de Góes Cavalcanti L. How much of the
current serious arbovirus epidemic in Brazil is dengue and how much
is chikungunya? Lancet Reg Health Am. 2024 Apr 30;34:100753. doi:
10.1016/j.lana.2024.100753. PMID: 38711542; PMCID: PMC11070701.
Grafico Azioni Bavarian Nordic AS (TG:BV3)
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