Bavarian Nordic Completes BLA Submission to U.S. FDA for its Chikungunya Vaccine Candidate
17 Giugno 2024 - 4:21PM
Bavarian Nordic Completes BLA Submission to U.S. FDA for its
Chikungunya Vaccine Candidate
- First regulatory submission completed for CHIKV VLP seeking
approval of the vaccine candidate for immunization against
chikungunya virus infection in individuals 12 years of age and
older
- Represents first BLA for a chikungunya vaccine for
adolescents
COPENHAGEN, Denmark, June 17,
2024 – Bavarian Nordic A/S (OMX: BAVA) today announced the
completion of the rolling submission process which was initiated in
April 2024 with the U.S. Food and Drug Administration (FDA) for a
Biologics License Application (BLA) for the licensure of its CHIKV
VLP vaccine candidate for immunization against chikungunya virus
infection in individuals 12 years of age and older. Pending
acceptance from the FDA, the BLA could support a potential approval
of the vaccine in the first half of 2025.
The BLA submission includes results from two
phase 3 clinical trials in more than 3,600 healthy individuals 12
years of age and older, demonstrating that the CHIKV VLP vaccine
was highly immunogenic, as demonstrated by the strong induction of
chikungunya neutralizing antibodies against chikungunya 21 days
after vaccination, with antibody titers equal to or above the
threshold agreed with authorities as a marker of seroprotection.
The CHIKV VLP vaccine was well-tolerated across both studies and
vaccine-related adverse events were mainly mild or moderate in
nature.
Bavarian Nordic also intends to submit a
Marketing Authorisation Application (MAA) with the European
Medicines Agency (EMA) by the end of the first half 2024. The MAA
has already been granted accelerated assessment, which means the
CHIKV VLP vaccine could potentially obtain approval by the European
Commission in the first half of 2025.
“The completion of the BLA submission marks a
significant milestone in the development of our CHIKV VLP vaccine
and represents an important contribution to the development of
preventative solutions for individuals 12 years of age and older at
risk of chikungunya virus from bites by infected mosquitos. With
the near-term anticipated MAA submission to EMA, we are looking
towards potential approval of the vaccine in the first half of 2025
and subsequent launch in both the US and EU,” said Paul
Chaplin, President and CEO of Bavarian Nordic.
About CHIKV VLPCHIKV VLP is an
adjuvanted VLP-based vaccine candidate for active immunization
against chikungunya disease. 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.
About chikungunyaChikungunya 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 NordicBavarian
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.
ContactsEurope: 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. 18 / 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)
Storico
Da Ott 2024 a Nov 2024
Grafico Azioni Bavarian Nordic AS (TG:BV3)
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Da Nov 2023 a Nov 2024
