EMA Accepts Valneva’s Chikungunya Vaccine Marketing Authorization
Application for Accelerated Assessment
Saint-Herblain (France), November 27,
2023 – Valneva SE (Nasdaq: VALN; Euronext Paris: VLA), a
specialty vaccine company, today announced that the European
Medicines Agency (EMA) has performed a technical validation of the
Marketing Authorization Application (MAA) for Valneva’s single-shot
chikungunya vaccine candidate VLA1553 and has determined that all
essential regulatory elements required for scientific assessment
were included in the application. The MAA was granted accelerated
assessment1 last month by EMA’s Committee for Medicinal Products
for Human Use (CHMP) based on the vaccine candidate’s “major
interest for public health and therapeutic innovation”2.
Accelerated assessment reduces the timeframe for
EMA’s CHMP to review a MAA once it is accepted for review from 210
days under the standard review procedure to 150 days. This does
not, however, include clock stops when applicants must provide
additional information during the review process, which is common
in review procedures.
Juan Carlos Jaramillo, MD, Chief Medical
Officer of Valneva, commented, “We welcome EMA’s MAA
review acceptance and will work closely with them to bring VLA1553
to market. Chikungunya virus, or CHIKV, has already spread to over
110 countries and the risk of chikungunya spreading in Europe is
relatively high due to the possibility of infected travelers3. No
vaccine or specific treatments are currently available for this
debilitating disease which therefore constitutes an unmet medical
need. Following approval of VLA1553 in the United States4, we will
continue to work diligently to bring VLA1553 to other territories
as soon as possible.”
VLA1553 received approval from the U.S. Food and
Drug Administration (FDA)5 at the beginning of the month under the
brand name IXCHIQ®. In the U.S., the vaccine is indicated for the
prevention of disease caused by the chikungunya virus (CHIKV) in
individuals 18 years of age and older who are at increased risk of
exposure to CHIKV.
Mid-November, Valneva also reported positive
pivotal Phase 3 immunogenicity data in adolescents for VLA1553
which are intended to support label extension in this age group6.
The trial is also expected to support licensure of the vaccine in
Brazil, which would be the first potential approval for use in
endemic populations.
About ChikungunyaChikungunya is
a mosquito-borne viral disease caused by the chikungunya virus
(CHIKV), a Togaviridae virus, transmitted by Aedes mosquitoes.
Infection leads to symptomatic disease in up to 97% of humans after
four to seven days following the mosquito bite7. While mortality
with CHIKV is low, morbidity is high, and the global market for
vaccines against chikungunya is estimated to exceed $500 million
annually by 20328. Clinical symptoms include acute onset of fever,
debilitating joint and muscle pain, headache, nausea, rash and
chronic arthralgia. 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. The high-risk areas of infection for travelers are
places where chikungunya virus-carrying mosquitos are endemic,
including the Americas, parts of Africa, and Southeast Asia, and
the virus has spread to more than 110 countries9. Between 2013 and
2023, more than 3.7 million cases were reported in the Americas10
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. In
Europe, there is no preventive vaccines or effective treatments
available and, as such, chikungunya is considered a major public
health threat.
About VLA1553VLA1553 is a
live-attenuated, single dose investigational vaccine candidate
targeting the chikungunya virus, which has spread to over 110
countries11. It has been designed by deleting a part of the
chikungunya virus genome.Valneva reported final data from the
pivotal Phase 3 trial of VLA1553 in March 202212, final lot-to-lot
consistency results in May 202213, positive twelve-month
persistence data in December 202214 and positive pivotal Phase 3
data in adolescents in November 202315. 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 VLA155316. The
collaboration falls within the framework of the agreement signed
between CEPI and Valneva in July 201917, which provides funding of
up to $24.6 million with support from the European Union’s Horizon
2020 program.VLA1553 received FDA approval in November 2023 under
the brand name IXCHIQ® and is indicated for the prevention of
disease caused by CHIKV in individuals 18 years of age and older
who are at increased risk of exposure to CHIKV. Continued approval
of IXCHIQ® in the United States is contingent upon verification of
clinical benefit in confirmatory studies. VLA1553 was also granted
PRIority MEdicine (PRIME) designation and accelerated assessment by
the European Medicines Agency (EMA) in 2020 and 2023
respectively.The Company intends to commercialize this vaccine by
leveraging its existing manufacturing and commercial
operations.
About Valneva SEWe are a
specialty vaccine company that develops, manufactures, and
commercializes prophylactic vaccines for infectious diseases
addressing unmet medical needs. We take a highly specialized and
targeted approach, applying our deep expertise across multiple
vaccine modalities, focused on providing either first-, best- or
only-in-class vaccine solutions.
We have a strong track record, having advanced
multiple vaccines from early R&D to approvals, and currently
market two proprietary travel vaccines as well as certain
third-party vaccines leveraging our established commercial
infrastructure.
Revenues from our growing commercial business
help fuel the continued advancement of our vaccine pipeline. This
includes the only Lyme disease vaccine candidate in advanced
clinical development, which is partnered with Pfizer, potentially
the world’s first vaccine against the chikungunya virus, as well as
vaccine candidates against the Zika virus and other global public
health threats.
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 Accelerated assessment | European Medicines Agency
(europa.eu)2 Valneva Submits Chikungunya Vaccine Marketing
Application to EMA and Announces CHMP Accelerated Assessment3
https://www.ecdc.europa.eu/en/chikungunya/threats-and-outbreaks/risk-assessment-chikungunya-eu4 Valneva
Announces U.S. FDA Approval of World’s First Chikungunya Vaccine,
IXCHIQ® - Valneva5 Valneva Announces U.S. FDA Approval of
World’s First Chikungunya Vaccine, IXCHIQ® - Valneva6 Valneva
Reports Positive Pivotal Phase 3 Immunogenicity Data in Adolescents
for its Single-Shot Chikungunya Vaccine Candidate - Valneva7
Staples, J.E. Hills, S.L. Powers, A.M. "Chikungunya." In CDC Yellow
Book 2020: Health Information for International Travel, by Centers
for Disease Control and Prevention. New York: Oxford University
Press, 20208 VacZine Analytics Chikungunya virus vaccines Global
demand analysis. February 20209
https://www.who.int/news-room/fact-sheets/detail/chikungunya10
PAHO/WHO data: Number of reported cases of chikungunya fever in the
Americas (Cumulative Cases 2018-2023 and Cases per year 2013-2017).
https://www.paho.org/data/index.php/en/mnu-topics/chikv-en/550-chikv-weekly-en.html.
Last accessed 01 Aug 2023.11
https://www.who.int/news-room/fact-sheets/detail/chikungunya12
Valneva Successfully Completes Pivotal Phase 3 Trial of Single-Shot
Chikungunya Vaccine Candidate13 Valneva Successfully Completes
Lot-to-Lot Consistency Trial for its Single-Shot Chikungunya
Vaccine Candidate14 Valneva Reports Positive 12-Month Antibody
Persistence Data for Single-Shot Chikungunya Vaccine Candidate -
Valneva15 Valneva Reports Positive Pivotal Phase 3 Immunogenicity
Data in Adolescents for its Single-Shot Chikungunya Vaccine
Candidate - Valneva16 Valneva and Instituto Butantan Sign Final
Agreement on Single-Shot Chikungunya Vaccine for Low and Middle
Income Countries17 CEPI awards up to $23.4 million to Valneva for
late-stage development of a single-dose Chikungunya vaccine
- 2023_11_27_VLA1553_EMA_Filing_Acceptance_PR_EN_Final
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