[ad_1]
Saint-Herblain (France), May30, 2023 – ValnevaSE (Nasdaq: VALN; Euronext Paris: VLA), a specialty vaccine firm, at this time declares the submitting of a regulatory software with Health Canada for advertising and marketing approval of the Company’s single-shot chikungunya vaccine candidate, VLA1553, in individuals aged 18 years and above. If accepted, Health Canada will present further info on the potential approval timeline.
This is the second regulatory software for VLA1553 filed by Valneva, and the Company intends to make further regulatory submissions in 2023. A Biologic License Application (BLA) is at present below precedence evaluate1 by the U.S. Food and Drug Administration (FDA) with a Prescription Drug User Fee Act (PDUFA) evaluate objective date on the finish of August 2023.
VLA1553 is at present the one chikungunya vaccine candidate worldwide for which regulatory evaluate processes are underway and, if accepted, it might change into the primary licensed chikungunya vaccine out there to deal with this unmet medical want. It would additionally characterize the third vaccine Valneva has introduced from early R&D to approval.
Juan Carlos Jaramillo, MD, Chief Medical Officer of Valneva, commented, “Chikungunya represents a major threat for people traveling to or living in areas where chikungunya virus and the mosquitos that transmit it are present, including popular destinations for U.S. and Canadian travelers. This threat continues to grow as shown by the recent epidemiological alert of the Pan American Health Organization (PAHO)2. No vaccine or specific treatments are currently available for this debilitating disease, and we will continue to work diligently to bring VLA1553 to different territories as soon as possible.”
The regulatory submissions with Health Canada and the FDA comply with remaining pivotal Phase 3 knowledge in March 20223, remaining lot-to-lot consistency leads to May 20224 and constructive twelve-month persistence knowledge in December 20225. A scientific examine of VLA1553 in adolescents is ongoing in Brazil6, for which Valneva reported enrollment and vaccination completion in February 20237. This trial, performed by Valneva’s associate Instituto Butantan and funded by the Coalition for Epidemic Preparedness Innovations (CEPI), could help future regulatory submissions on this age group, if VLA1553 is initially accepted in adults, in addition to licensure of the vaccine in Europe and Brazil, which might be the primary potential approval to be used in an endemic inhabitants. First outcomes are anticipated mid-2023.
VLA1553 obtained FDA Fast Track and Breakthrough Therapy designations in 2018 and 2021, respectively. The program was additionally granted PRIority MEdicine (PRIME) designation by the European Medicines Agency (EMA) in 2020, and Valneva plans to make regulatory submissions for VLA1553 in Europe within the second half of 2023.
About Chikungunya
Chikungunya is a mosquito-borne viral illness brought on by the chikungunya virus (CHIKV), a Togaviridae virus, transmitted by Aedes mosquitoes. Infection results in symptomatic illness in 72-92% of people after 4 to seven days following the mosquito chew. While mortality with CHIKV is low, morbidity is excessive, and the worldwide marketplace for vaccines towards chikungunya is estimated to exceed $500 million yearly by 20328. Clinical signs embody acute onset of fever, debilitating joint and muscle ache, headache, nausea, rash and persistent arthralgia. Chikungunya virus usually causes sudden giant outbreaks with excessive assault charges, affecting one-third to three-quarters of the inhabitants in areas the place the virus is circulating. The high-risk areas of an infection for vacationers are locations the place chikungunya virus-carrying mosquitos are endemic, together with the Americas, elements of Africa, and Southeast Asia, and the virus has unfold to greater than 110 nations9. As of July 2022, greater than three million instances have been reported within the Americas10 and the financial impression is taken into account to be vital. The medical and financial burden is predicted to develop because the CHIKV main mosquito vectors proceed to unfold geographically. There are not any preventive vaccines or efficient remedies out there and, as such, chikungunya is taken into account to be a serious public well being risk.
About VLA1553
VLA1553 is a live-attenuated, single dose investigational vaccine candidate focusing on the chikungunya virus, which has unfold to over 110 nations11. It has been designed by deleting part of the chikungunya virus genome.
Valneva reported remaining knowledge from the pivotal Phase 3 trial of VLA1553 in March 202212, remaining lot-to-lot consistency leads to May 202213 and constructive twelve-month persistence knowledge in December 202214.
If accepted, VLA1553 would increase Valneva’s current business vaccines portfolio and as such, Valneva intends to commercialize this vaccine, leveraging its current manufacturing and business operations.
To make VLA1553 extra accessible to Low- and Middle-Income Countries (LMIC), Valneva and Instituto Butantan in Brazil signed an settlement in January 2021 for the event, manufacturing and advertising and marketing of VLA155315. The collaboration falls inside the framework of the settlement signed between CEPI and Valneva in July 201916, which gives funding of as much as $24.6 million with help from the European Union’s Horizon 2020 program.
VLA1553 obtained FDA Fast Track, Breakthrough Therapy designations and Priority Review in 2018, 2021 and 2023, respectively. VLA1553 was additionally granted PRIority MEdicine (PRIME) designation by the European Medicines Agency (EMA) in 2020.
About Valneva SE
We are a specialty vaccine firm targeted on the event, manufacturing and commercialization of prophylactic vaccines for infectious illnesses. We take a extremely specialised and focused method to vaccine growth by specializing in vaccine options addressing unmet medical wants to make sure we are able to make a distinction to peoples’ lives. We apply our deep understanding of vaccine science, together with our experience throughout a number of vaccine modalities, and our established vaccine growth capabilities, to develop vaccines towards illnesses which aren’t but vaccine-preventable, or for which there are restricted efficient remedy choices. Today, we’re leveraging our experience and capabilities to quickly advance a broad vary of vaccines into and thru the clinic, together with candidates towards the chikungunya virus and Lyme illness.
| Media & Investor Contacts Laëtitia Bachelot-Fontaine VP Global Communications & European Investor Relations M +33 (0)6 4516 7099 laetitia.bachelot-fontaine@valneva.com |
Joshua Drumm, Ph.D. |
Forward-Looking Statements
This press launch incorporates sure forward-looking statements referring to the enterprise of Valneva, together with with respect to regulatory approval of VLA1553 and timing and plans for scientific applications and scientific trials. In addition, even when the precise outcomes or growth of Valneva are in step with the forward-looking statements contained on this press launch, these outcomes or developments of Valneva will not be indicative of future outcomes. In some instances, you may determine forward-looking statements by phrases reminiscent of “could,” “should,” “may,” “expects,” “anticipates,” “believes,” “intends,” “estimates,” “aims,” “targets,” or related phrases. These forward-looking statements are based mostly on the present expectations of Valneva as of the date of this press launch and are topic to a variety of recognized and unknown dangers and uncertainties and different elements which will trigger precise outcomes, efficiency or achievements to be materially totally different from any future outcomes, efficiency or achievement expressed or implied by these forward-looking statements. In explicit, the expectations of Valneva may very well be affected by, amongst different issues, uncertainties concerned within the growth and manufacture of vaccines, surprising scientific trial outcomes, surprising regulatory actions or delays, competitors typically, foreign money fluctuations, the impression of the worldwide and European credit score disaster, the power to acquire or keep patent or different proprietary mental property safety and the impression of the COVID-19 pandemic. In gentle of those dangers and uncertainties, there could be no assurance that the forward-looking statements made on this press launch will in reality be realized. Valneva is offering the data on this press launch as of the date hereof and disclaims any intention or obligation to publicly replace or revise any forward-looking statements, whether or not because of new info, future occasions, or in any other case.
1FDA Accepts Valneva’s Chikungunya Vaccine License Application for Priority Review – Valneva
2https://www.paho.org/en/documents/epidemiological-alert-chikungunya-increase-region-americas
3Valneva Successfully Completes Pivotal Phase 3 Trial of Single-Shot Chikungunya Vaccine Candidate
4Valneva Successfully Completes Lot-to-Lot Consistency Trial for its Single-Shot Chikungunya Vaccine Candidate
5Valneva Reports Positive 12-Month Antibody Persistence Data for Single-Shot Chikungunya Vaccine Candidate – Valneva
6Valneva Announces Initiation of Adolescent Phase 3 Trial for its Single-Shot Chikungunya Vaccine Candidate – Valneva
7Valneva Completes Enrollment for Adolescent Phase 3 Trial of Single-Shot Chikungunya Vaccine Candidate – Valneva
8 VacZine Analytics Chikungunya virus vaccines Global demand evaluation. February 2020
9https://www.who.int/news-room/fact-sheets/detail/chikungunya
10 PAHO/WHO knowledge: Number of reported instances of chikungunya fever within the Americas (Cumulative Cases 2018-2022 and Cases per yr 2013-2017). https://www.paho.org/data/index.php/en/mnu-topics/chikv-en/550-chikv-weekly-en.html. Last accessed 25 Jul 2022.
11https://www.who.int/news-room/fact-sheets/detail/chikungunya
12 Valneva Successfully Completes Pivotal Phase 3 Trial of Single-Shot Chikungunya Vaccine Candidate
13 Valneva Successfully Completes Lot-to-Lot Consistency Trial for its Single-Shot Chikungunya Vaccine Candidate
14Valneva Reports Positive 12-Month Antibody Persistence Data for Single-Shot Chikungunya Vaccine Candidate – Valneva
15 Valneva and Instituto Butantan Sign Final Agreement on Single-Shot Chikungunya Vaccine for Low and Middle Income Countries
16 CEPI awards up to $23.4 million to Valneva for late-stage development of a single-dose Chikungunya vaccine
Attachment
[adinserter block=”4″]
[ad_2]
Source link