Valneva Announces PDUFA Date Extension for Chikungunya Virus Vaccine Candidate
2023年8月14日 - 2:00PM
Valneva Announces PDUFA Date Extension for Chikungunya Virus
Vaccine Candidate
Saint-Herblain
(France), August
14,
2023 – Valneva
SE (Nasdaq: VALN; Euronext Paris: VLA), a specialty vaccine
company, today announced that the U.S. Food and Drug Administration
(FDA) has revised the Prescription Drug User Fee Act (PDUFA) action
date for the Biologics License Application (BLA) for VLA1553,
Valneva’s chikungunya virus vaccine candidate, from the previously
communicated end of August to the end of November.
The FDA extended the PDUFA date to allow sufficient
time to align and agree on the phase 4 program necessary under the
accelerated approval pathway. No additional clinical data have been
requested for the approval process.
Valneva is committed to working with the FDA in its
ongoing review of the BLA, and to potentially delivering the
world’s first chikungunya vaccine. The Company reconfirms its
previous guidance for potential BLA approval, initial launch, and
potential award of a priority review voucher (PRV) still in 2023.
This PDUFA extension does not impact Valneva’s current regulatory
submission in Canada or its planned submission with the European
Medicines Agency (EMA).
Juan Carlos Jaramillo,
Chief Medical Officer of
Valneva, said, “We appreciate and take pride in the fact
that our BLA for VLA1553, if approved, will represent the first
vaccine candidate to be approved under the accelerated approval
pathway in an outbreak disease, and hence the necessary Phase 4
activities will set a future standard. We are continuing to work
closely and collaboratively with the FDA, and we believe it may be
possible to obtain an approval before the new PDUFA
date.”About Valneva SEWe are a specialty vaccine
company focused on the development, manufacturing and
commercialization of prophylactic vaccines for infectious diseases.
We take a highly specialized and targeted approach to vaccine
development by focusing on vaccine solutions addressing unmet
medical needs to ensure we can make a difference to peoples’ lives.
We apply our deep understanding of vaccine science, including our
expertise across multiple vaccine modalities, and our established
vaccine development capabilities, to develop vaccines against
diseases which are not yet vaccine-preventable, or for which there
are limited effective treatment options. Today, we are leveraging
our expertise and capabilities to rapidly advance a broad range of
vaccines into and through the clinic, including candidates against
Lyme disease, the chikungunya virus.
Valneva
Investor and Media ContactsLaetitia Bachelot-FontaineVP
Global Communications & European Investor RelationsM +33 (0)6
4516
7099laetitia.bachelot-fontaine@valneva.com |
Joshua
Drumm, Ph.D.VP Global Investor RelationsM +001 917 815
4520joshua.drumm@valneva.com |
Forward-Looking StatementsThis
press release contains certain forward-looking statements relating
to the business of Valneva, including with respect to the progress,
timing, results and completion of research, development and
clinical trials for product candidates, to regulatory approval of
product candidates and review of existing products. In addition,
even if the actual results or development of Valneva are consistent
with the forward-looking statements contained in this press
release, those results or developments of Valneva may not be
sustained in the future. In some cases, you can identify
forward-looking statements by words such as “could,” “should,”
“may,” “expects,” “anticipates,” “believes,” “intends,”
“estimates,” “aims,” “targets,” or similar words. These
forward-looking statements are based largely on the current
expectations of Valneva as of the date of this press release and
are subject to a number of known and unknown risks and
uncertainties and other factors that may cause actual results,
performance or achievements to be materially different from any
future results, performance or achievement expressed or implied by
these forward-looking statements. In particular, the expectations
of Valneva could be affected by, among other things, uncertainties
and delays involved in the development and manufacture of vaccines,
unexpected clinical trial results, unexpected regulatory actions or
delays, competition in general, currency fluctuations, the impact
of the global and European credit crisis, and the ability to obtain
or maintain patent or other proprietary intellectual property
protection. Success in preclinical studies or earlier clinical
trials may not be indicative of results in future clinical trials.
In light of these risks and uncertainties, there can be no
assurance that the forward-looking statements made during this
presentation will in fact be realized. Valneva is providing the
information in these materials as of this press release and
disclaim any intention or obligation to publicly update or revise
any forward-looking statements, whether as a result of new
information, future events, or otherwise.
- 2023_08_14_VLA1553_PDUFA_Extension_PR_EN_Final
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