Valneva Announces U.S. FDA Approval of World’s First Chikungunya
Vaccine, IXCHIQ®
Saint-Herblain (France), November 10,
2023 – Valneva SE (Nasdaq: VALN; Euronext Paris: VLA), a
specialty vaccine company, today announced that the U.S. Food and
Drug Administration (FDA) has approved IXCHIQ®, Valneva’s
single-dose, 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. This indication is approved under accelerated approval based
on anti-CHIKV neutralizing antibody titers. Continued approval for
this indication is contingent upon verification of clinical benefit
in confirmatory studies.
The Company will hold an analyst call and a
webcast at 3:00pm CET or 9:00am EDT on Monday, November 13, 2023.
The link will be available on the Company’s investor page. Please
refer to this link Investors - Valneva.
As sponsor of the first chikungunya vaccine
approved in the U.S., Valneva has received a Priority Review
Voucher (PRV) from the FDA, which it intends to monetize to help
finance its research and development (R&D) programs.
With this U.S. approval, IXCHIQ® becomes the
world’s first licensed chikungunya vaccine available to address
this unmet medical need and the third vaccine Valneva1 has brought
from early R&D to approval. Valneva reported final pivotal
Phase 3 data for the vaccine in March 2022 showing a 98.9%
seroresponse rate at 28 days with a single vaccination2 and final
lot-to-lot consistency results in May 20223. IXCHIQ®-induced
seroresponse was sustained over time with a 96.3% seroresponse rate
six months post-vaccination2. Valneva will continue to evaluate
antibody persistence for at least five years4. The Company’s
pivotal Phase 3 results were published in the Lancet in June
2023.
Every year, more than 60 million Americans
travel to countries where mosquito-borne diseases are endemic5.
Initially addressing the potential needs of U.S. travelers, IXCHIQ®
fits seamlessly into Valneva’s global established travel vaccines
business, which includes vaccines against Japanese encephalitis and
cholera/ETEC6, leveraging Valneva’s existing commercial and
industrial infrastructure, which has been augmented with this
newest product.
Valneva plans to begin commercializing IXCHIQ®
in the U.S. early next year while continuing to support the work
towards an anticipated vote from the Advisory Committee on
Immunization Practices (ACIP) at the end of February 2024.
Thomas Lingelbach, Chief Executive
Officer of Valneva, said, “As a leading specialty vaccines
company, we aim to deliver vaccines in areas of unmet medical need
supporting our vision to contribute to a world in which no one dies
or suffers from a vaccine preventable disease. As such, today marks
an important step forward in the prevention of chikungunya. I would
like to personally express a huge thank you to everyone who helped
make this possible. I would also like to recognize CEPI and
Instituto Butantan for their collaboration in potentially bringing
this product to low- and middle-income countries.”
Dr. Richard Hatchett, Chief Executive
Officer of the Coalition for Epidemic Preparedness
Innovations (CEPI), commented, “The
first-ever licensed chikungunya vaccine will play a crucial role in
preventing the suffering caused by this debilitating disease.
Climate change is intensifying the threat posed by chikungunya,
which means safe and effective vaccines are needed now more than
ever before. Through our partnership with Valneva and Instituto
Butantan, CEPI – with support from the EU – will help to make this
vaccine accessible to the people most affected by the virus in low-
and middle-income countries. I am proud of our contribution and
congratulate our partner Valneva on this historic achievement.”
Juan Carlos Jaramillo M.D., Chief
Medical Officer of Valneva, added, “Today, it is estimated
that more than 75% of the world's population lives in areas at risk
of CHIKV transmission due to factors such as global warming and
climate change7. Chikungunya has already spread to over 110
countries and is currently regarded as one of the most likely viral
infections to emerge in new geographic areas. Morbidity is high
with 43% of CHIKV patients suffering from chronic chikungunya where
joint pain, fatigue, and potentially debilitating effects may last
from months to years and can have substantial impact on daily
activities7,8. As we are introducing IXCHIQ®, our objective is to
make this vaccine available to the largest number of people that
will benefit from it.”
Earlier this year, the Pan American Health
Organization (PAHO) issued an epidemiological alert as the number
of cases and deaths due to chikungunya continues to rise in the
Americas9. Modeling now shows the problem may only worsen due to
climate change. As the Earth’s temperature continues to rise,
vector habitats are likely to expand, which poses an immediate risk
of outbreaks in warmer areas of the United States and Europe10.
A clinical study in adolescents, aged 12 to 17
years, is ongoing in Brazil11 as part of an agreement signed
between Instituto Butantan and Valneva in January 202112 to make
the vaccine more accessible to Low- and Middle-Income Countries
(LMIC). The study, funded by the Coalition for Epidemic
Preparedness Innovations (CEPI), may support future regulatory
submissions in this age group as well as licensure of the vaccine
in Brazil, which would be the first potential approval for use in
an endemic region.
The study is also expected to support regulatory
approval in Europe. Initial safety data from this trial were
included in the submission to the European Medicines Agency (EMA)
in October 202313. The vaccine was granted PRIority MEdicine
(PRIME) designation by EMA in 2020. A regulatory review is
currently also underway with Health Canada.
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 bite14. 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 203215. 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 countries16. Between 2013 and
2023, more than 3.7 million cases were reported in the Americas17
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.
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.
IXCHIQ®
(chikungunya virus, live) Solution for Intramuscular
Injection
IndicationIXCHIQ® is a vaccine
indicated for the prevention of disease caused by chikungunya virus
(CHIKV) in individuals 18 years and older who are at increased risk
of exposure to CHIKV. This indication is approved under accelerated
approval based on anti-CHIKV neutralizing antibody titers.
Continued approval for this vaccine is contingent upon verification
and description of clinical benefit in confirmatory studies.
IMPORTANT SAFETY INFORMATION ABOUT
IXCHIQ® – Please consult the full
prescribing information for all the labeled safety information.
ContraindicationsIXCHIQ® should
not be given to individuals who have a weakened immune system due
to medications used for hematologic and solid tumors, on
chemotherapy, history of congenital immunodeficiency, long-term
immunosuppressive therapy, or patients with HIV infection who are
severely immunocompromised.
Individuals with a history of a severe allergic
reaction to any component of the vaccine.
WarningsAppropriate
medical treatment used to manage immediate allergic
reactions must be available in the event an acute
anaphylactic reaction following administration of
IXCHIQ® or any vaccine.
Vaccination with
IXCHIQ® may cause severe or
prolonged chikungunya-like adverse reactions. Severe
chikungunya-like adverse reactions that prevented daily activity
and/or required medical intervention occurred in 1.6% of 3,082
IXCHIQ® recipients and no placebo recipients.
Fourteen IXCHIQ® recipients had prolonged
(duration at least 30 days) chikungunya-like adverse reactions.
Infection of pregnant individuals with
wild-type chikungunya virus can result in
intra-partum transmission and potentially fatal neonatal
complications. IXCHIQ® should be
administered during pregnancy only after an individual risk-benefit
assessment, considering maternal risk of chikungunya infection and
gestational age.
Fainting can occur with administration of
IXCHIQ®. Procedures should be in place to avoid
injury from fainting.
IXCHIQ®
may not protect all individuals who receive the
vaccine.
Adverse ReactionsThe most
common injection site reaction (>10%) was tenderness (11%) and
the most common systemic adverse reactions (>10%) were headache
(31%), fatigue (29%), myalgia (24%), arthralgia (17%), fever (13%)
and nausea (11%).
Use in Specific Populations
Pregnancy
There are no adequate and well-controlled
studies of IXCHIQ® in pregnant individuals, and
human data available from clinical trials with
IXCHIQ® are insufficient to establish the presence
or absence of vaccine-associated risk during pregnancy.
Please click here for
full 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 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 This statement refers to Valneva and its predecessor
Intercell2 Valneva Successfully Completes Pivotal Phase 3 Trial of
Single-Shot Chikungunya Vaccine Candidate3 Valneva Successfully
Completes Lot-to-Lot Consistency Trial for its Single-Shot
Chikungunya Vaccine Candidate4 Valneva Reports Positive 12-Month
Antibody Persistence Data for Single-Shot Chikungunya Vaccine
Candidate5
https://www.trade.gov/feature-article/us-citizen-international-outbound-travel-six-percent-20186
Indications differ by country – Please refer to Product /
Prescribing Information (PI) / Medication Guide approved in your
respective countries for complete information, incl. dosing, safety
and age groups in which this vaccine is licensed; ETEC =
Enterotoxigenic Escherichia coli (E. Coli) bacterium7 Puntasecca
CJ, King CH, LaBeaud AD. "Measuring the global burden of
chikungunya and Zika viruses: A systematic review." PLOS Negl Trop
Dis 15, no. 3 (2021): e0009055.8 Paixão, E. S., Rodrigues, L. C.,
Costa, M., Itaparica, M., Barreto, F., Gérardin, P., &
Teixeira, M. G. "Chikungunya chronic disease: a systematic review
and meta-analysis." Transactions of the Royal Society of Tropical
Medicine and Hygiene 7, no. 112 (2018): 301-3169 Pan American
Health Organization / World Health Organization. Epidemiological
Alert: Chikungunya increase in the Region of the Americas. 13
February 2023, Washington, D.C. PAHO / WHO. 2023
https://www.paho.org/en/documents/epidemiological-alert-chikungunya-increase-region-americas
accessed August 202310 Rocklöv, J., Dubrow, R. Climate change: an
enduring challenge for vector-borne disease prevention and
control. Nat Immunol 21, 479–483 (2020).
https://doi.org/10.1038/s41590-020-0648-y11 Valneva Announces
Initiation of Adolescent Phase 3 Trial for its Single-Shot
Chikungunya Vaccine Candidate – Valneva12 Valneva and Instituto
Butantan Sign Final Agreement on Single-Shot Chikungunya Vaccine
for Low and Middle Income Countries13 Valneva Submits Chikungunya
Vaccine Marketing Application to EMA and Announces CHMP Accelerated
Assessment14 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, 202015 VacZine Analytics Chikungunya virus
vaccines Global demand analysis. February 202016
https://www.who.int/news-room/fact-sheets/detail/chikungunya17
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.
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