Bavarian Nordic’s Chikungunya Vaccine Candidate Granted Accelerated Assessment by European Medicines Agency
2024年2月23日 - 3:35PM
Bavarian Nordic’s Chikungunya Vaccine Candidate Granted Accelerated
Assessment by European Medicines Agency
- Accelerated assessment allows for a shorter review period with
EMA.
- Bavarian Nordic is on track to submit its Marketing
Authorisation Application for CHIKV VLP to EMA during H1 2024.
COPENHAGEN, Denmark, February 23, 2024 –
Bavarian Nordic A/S (OMX: BAVA) (“the Company”) today announced
that the Committee for Medicinal Products for Human Use (CHMP) of
the European Medicines Agency (EMA) has granted accelerated
assessment for the upcoming Marketing Authorisation Application
(MAA) for CHIKV VLP, the Company’s investigational chikungunya
vaccine.
The accelerated assessment, which is granted
based upon CHMP’s decision that the vaccine candidate is of major
interest for public health and therapeutic innovation, may reduce
the timeframe for the review of the MAA from 210 days under the
standard review procedure to 150 days, not counting clock stops
when applicants must provide additional information1.
Bavarian Nordic is on track and plans to submit
its MAA for CHIKV VLP to the EMA during H1 2024.
“We are pleased to receive the accelerated
assessment in recognition of our chikungunya vaccine candidate and
our efforts to bring this novel product to the market. With this,
we have the ability to accelerate the approval and our launch
timelines for the vaccine in Europe. As part of our global
strategy, we also plan to submit our biologics license application
(BLA) for the vaccine candidate to the U.S. Food and Drug
Administration later this year,” said Paul Chaplin, President and
CEO of Bavarian Nordic.
In 2023, Bavarian Nordic successfully completed
two Phase 3 studies of CHIKV VLP. Both studies met their primary
endpoints, demonstrating that CHIKV VLP induced high levels of
neutralizing antibodies against chikungunya in individuals 12 years
and above, with antibody titers equal to or above the threshold
agreed with authorities as a marker of seroprotection.
One study (NCT05072080) enrolled 3,254 healthy
adults and adolescents aged 12 to 64 years of age, who were
randomized to receive either a single intramuscular injection of
CHIKV VLP, or placebo. The results up to day 22 post vaccination
showed that CHIKV VLP was highly immunogenic, as demonstrated by
the strong induction of chikungunya neutralizing antibodies in 98%
of vaccinees in the active group.
Importantly, CHIKV VLP induced significant
neutralizing antibodies in 47% and 97% of the subjects after 8 days
and 15 days post vaccination respectively. These responses were
robust and durable, as 86% of the subjects had seroprotective
levels of neutralizing antibodies 6 months post vaccination.
A similar study, which enrolled 413 healthy
adults ≥65 years of age (NCT05349617), showed neutralizing
antibodies in 87% of the vaccinees 22 days after a single
vaccination. Seroprotective antibodies were confirmed in 82% of the
individuals at day 15.
CHIKV VLP was well-tolerated across both studies
and vaccine-related adverse events were mainly mild or moderate in
nature.
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, Tel: +45 61 77 47 43US: Graham
Morrell, Paddock Circle Advisors, graham@paddockcircle.com, Tel: +1
781 686 9600
Company Announcement no. 02 / 2024
1
https://www.ema.europa.eu/en/human-regulatory-overview/marketing-authorisation/accelerated-assessment
Bavarian Nordic AS (TG:BV3)
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Bavarian Nordic AS (TG:BV3)
過去 株価チャート
から 6 2023 まで 6 2024