FDA Accepts Valneva’s Chikungunya Vaccine License Application for Priority Review
February 20 2023 - 1:00AM
Saint-Herblain
(France),
February 20,
2023 – Valneva
SE (Nasdaq: VALN; Euronext Paris: VLA), a specialty vaccine
company, today announced that the U.S. Food and Drug Administration
(FDA) has completed a filing review of its Biologics License
Application for Valneva’s single-shot chikungunya vaccine candidate
VLA1553 and has determined that the application is sufficiently
complete to permit a substantive review. The review classification
is Priority.
VLA1553 has been assigned a Prescription Drug
User Fee Act (PDUFA) review goal date at the end of August 2023,
which is the date by which the FDA intends to take action on the
application. The FDA’s acknowledgement of filing does not mean that
a license will be granted, nor does it represent any evaluation of
the adequacy of the data submitted.
About ChikungunyaChikungunya is
a mosquito-borne viral disease caused by the chikungunya virus
(CHIKV), a Togaviridae virus, transmitted by Aedes mosquitoes.
Chikungunya virus often causes sudden large outbreaks with high
attack rates, affecting one-third to three-quarters of the
population in areas where the virus is circulating. There are no
preventive vaccines or effective treatments available and, as such,
chikungunya is considered to be a major public health threat. As of
July 2022, there were more than 3 million reported cases in the
Americas1 and the economic impact is considered to be significant.
The medical and economic burden is expected to grow as the CHIKV
primary mosquito vectors continue to spread geographically.
Infection leads to symptomatic disease in up to 97% of humans after
three to seven days following the mosquito bite. While mortality
with CHIKV is low, morbidity is high. Clinical symptoms include
acute onset of fever, debilitating joint and muscle pain, headache,
nausea, rash and chronic arthralgia. It is estimated that over
three quarters of the world’s population live in areas at-risk of
CHIKV transmission2. High risk areas of infection are places where
chikungunya virus-carrying mosquitos are currently endemic,
including the Americas, parts of Africa, and Southeast Asia.
About
VLA1553VLA1553 is a live-attenuated,
single dose investigational vaccine candidate targeting the
chikungunya virus, which has spread to over 100 countries. It has
been designed by deleting a part of the chikungunya virus genome.To
make VLA1553 more accessible to Low- and Middle-Income Countries
(LMIC), Valneva and Instituto Butantan in Brazil signed an
agreement in January 2021 for the development, manufacturing and
marketing of VLA15533. The collaboration falls within the framework
of the agreement signed between CEPI and Valneva in July 20194,
which provides funding of up to $24.6 million with support from the
European Union’s Horizon 2020 program.Valneva reported final data
from the pivotal Phase 3 trial of VLA1553 in March 20225, final
lot-to-lot consistency results in May 20226 and positive
twelve-month persistence data in December 20227.If approved,
VLA1553 would expand Valneva’s existing commercial vaccines
portfolio and as such, Valneva intends to commercialize this
vaccine, leveraging its existing manufacturing and commercial
operations.
About Valneva SEValneva is a
specialty vaccine company focused on the development, manufacturing
and commercialization of prophylactic vaccines for infectious
diseases with significant unmet medical need. The Company takes a
highly specialized and targeted approach to vaccine development and
then applies its deep understanding of vaccine science to develop
prophylactic vaccines addressing these diseases. Valneva has
leveraged its expertise and capabilities both to commercialize
three vaccines and to rapidly advance a broad range of vaccine
candidates into and through the clinic, including candidates
against the chikungunya virus and Lyme disease.
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 Statements
This 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.
1 PAHO/WHO data: Number of reported cases of chikungunya fever
in the Americas
https://www.paho.org/data/index.php/en/mnu-topics/chikv-en/550-chikv-weekly-en.html.
Last accessed 25 Jul 20222 CDC 2022, Puntasecca CJ 20213 Valneva
and Instituto Butantan Sign Final Agreement on Single-Shot
Chikungunya Vaccine for Low and Middle Income Countries4 CEPI
awards up to $23.4 million to Valneva for late-stage development of
a single-dose Chikungunya vaccine5 Valneva Successfully Completes
Pivotal Phase 3 Trial of Single-Shot Chikungunya Vaccine Candidate6
Valneva Successfully Completes Lot-to-Lot Consistency Trial for its
Single-Shot Chikungunya Vaccine Candidate7 Valneva Reports Positive
12-Month Antibody Persistence Data for Single-Shot Chikungunya
Vaccine Candidate - Valneva
- 2023_02_20_VLA1553_BLA_Filing_Acceptance_PR_EN_Final
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