Valneva Receives EMA’s Positive CHMP Opinion for its Chikungunya
Vaccine
- If approved, IXCHIQ®
will become the first vaccine available in the EU against
the chikungunya virus (CHIKV)
- Decision on EU marketing authorization expected in the
third quarter of 2024
Saint Herblain (France), May 31,
2024 – Valneva SE (Nasdaq: VALN; Euronext Paris: VLA), a
specialty vaccine company, today announced that the Committee for
Medicinal Products for Human Use (CHMP) of the European Medicines
Agency (EMA) has adopted a positive opinion recommending
authorization of Valneva’s single-dose vaccine for the prevention
of disease caused by the chikungunya virus in individuals 18 years
of age and older.
The European Commission (EC) will review the
CHMP recommendation, and a decision on the marketing authorization
application of IXCHIQ® in the European Union (EU), Norway,
Liechtenstein and Iceland is expected in the third quarter of 2024.
If approved, it will become the first chikungunya vaccine available
in Europe to address this unmet medical need. In accordance with
the International Recognition Procedure (IRP)1, Valneva is also
preparing a Marketing Authorization Application (MAA) for
submission to the UK Medicines and Healthcare products Regulatory
Agency (MHRA).
The CHMP opinion follows the November 2023
approval of IXCHIQ® by the US Food and Drug Administration (FDA)2.
Two additional marketing authorization applications are currently
under review by Health Canada and the Brazilian Health Regulatory
Agency (ANVISA) with potential approvals in 2024.
Juan Carlos Jaramillo, M.D., Chief
Medical Officer of Valneva, commented, “This positive CHMP
opinion marks a crucial milestone toward introducing a preventative
solution against chikungunya in the EU. In recent years, climate
change has caused the Aedes mosquito, a known carrier of
chikungunya and dengue viruses, to spread to areas in Europe that
were previously unaffected. It is critical to provide a vaccine
solution not only to European travelers going to endemic
chikungunya areas, such as South America or Africa, but also to the
local European populations experiencing invasive mosquito attacks.
The broader we can make this vaccine accessible, the better we will
mitigate the burden of this debilitating illness, and we would like
to thank our partner, CEPI, for supporting us in this
endeavor.”
Dr. Richard Hatchett, Chief Executive
Officer of the Coalition for Epidemic Preparedness
Innovations (CEPI), commented, “Over one
billion people live in areas where Chikungunya is endemic, and
recent large outbreaks underline the urgent need for safe and
effective vaccines against this debilitating disease. Valneva’s
single-dose vaccine is well-suited for use in outbreak response and
in low-resource settings, and CEPI’s partnership with Valneva and
Instituto Butantan – supported by the EU – will help to make this
vaccine accessible to the people most affected by the virus in low-
and middle-income countries. Today’s positive opinion from the EMA
is an important step towards making the vaccine more widely
available.”
The positive CHMP opinion is supported by data
from the pivotal Phase 3 study which were published in The Lancet,
the world’s leading peer-reviewed medical journal, and showed a
98.9% seroresponse rate at 28 days with a single vaccination. This
robust immune response was sustained for 24 months by 97% of
participants and was equally durable in younger and older adults3.
Earlier this month, Valneva reported further positive pivotal data
in adolescents six months after a single vaccination, which are
intended to support filing for potential label extension for use in
adolescents aged 12 to 17 years4. The data are also expected to
support licensure of IXCHIQ® in Brazil, which would be the first
potential approval for use in an endemic population.
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 bite5. 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 20326. Clinical symptoms include acute onset of fever,
debilitating joint and muscle pain, headache, nausea, rash and
chronic arthralgia. The 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 countries7. Between 2013 and
2023, more than 3.7 million cases were reported in the Americas8
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. Before
IXCHIQ®, there were no preventive vaccines or
effective treatments available and, as such, chikungunya is
considered to be a major public health threat.
To make the vaccine 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 IXCHIQ®9. The
collaboration falls within the framework of the agreement signed
between CEPI and Valneva in July 201910, which provides funding of
up to $24.6 million with support from the European Union’s Horizon
2020 program. Regulatory review by the Brazilian authority ANVISA
is ongoing.
About
IXCHIQ®In the U.S., IXCHIQ® is a
live-attenuated vaccine indicated for the prevention of disease
caused by chikungunya virus (CHIKV) in individuals 18 years of age
and older who are at increased risk of exposure to CHIKV. As for
all products approved under FDA’s accelerated approval pathway,
continued approval for this indication is contingent upon
verification and description of clinical benefit in confirmatory
studies.Please click here for full U.S.
Prescribing Information for IXCHIQ®.
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 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 three 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, 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 International Recognition Procedure - GOV.UK
(www.gov.uk)2 Valneva Announces U.S. FDA Approval of World’s
First Chikungunya Vaccine, IXCHIQ® - Valneva3 Valneva Reports
Positive 24-Month Antibody Persistence Data for its Single-Shot
Chikungunya Vaccine IXCHIQ® - Valneva4 Valneva Reports Further
Positive Pivotal Phase 3 Data in Adolescents for its Single-Shot
Chikungunya Vaccine - Valneva5 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, 20206 VacZine
Analytics Chikungunya virus vaccines Global demand analysis.
February 20207
https://www.who.int/news-room/fact-sheets/detail/chikungunya8
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 2023.9 Valneva and Instituto Butantan Sign
Final Agreement on Single-Shot Chikungunya Vaccine for Low and
Middle Income Countries10 CEPI awards up to $23.4 million to
Valneva for late-stage development of a single-dose Chikungunya
vaccine
- 2024_05_31_IXCHIQ_CHMP_Positive_Opinion_PR_EN_Final
Valneva (LSE:0OB3)
Historical Stock Chart
From Sep 2024 to Oct 2024
Valneva (LSE:0OB3)
Historical Stock Chart
From Oct 2023 to Oct 2024