Biophytis Initiates the Regulatory Process for an Early Access Authorization in France from the French National Authority for Health (HAS) for the Treatment with Sarconeos (BIO101) of Severe Forms of COVID-19
- Biophytis to present the early access application in France at a pre-filing meeting in March with the HAS
- Biophytis plans to file the application shortly after with the objective of obtaining early access authorization in France in the second quarter of 2023
- Biophytis is pursuing in parallel the preparation of the conditional marketing authorization application due to the health emergency in Europe and the United States
PARIS, FRANCE / CAMBRIDGE, MA / ACCESSWIRE / February 27, 2023 / Biophytis SA ((NasdaqCM: BPTS, PARIS:ALBPS) (the "Company" or "Biophytis"), a biotechnology company focused on the development of drugs to slow the degenerative processes associated with aging, including severe respiratory failure in patients suffering from COVID-19, announced today that it has begun the process of early access application in France from the French National Authority for Health (HAS) for the treatment of severe COVID-19 with Sarconeos (BIO101). A pre-submission meeting with the HAS is scheduled for March and the application for early access authorisation should be submitted shortly after with the aim of obtaining authorisation in the second quarter of 2023. This programme would allow patients hospitalised in France with a severe form of COVID-19 to access treatment with Sarconeos (BIO101), which has been shown to reduce the risk of respiratory failure and early death by 44% in the positive phase 2-3 COVA clinical trial. Biophytis continues to prepare conditional marketing authorisation applications in Europe and in the US due to the health emergency.
Stanislas Veillet, CEO of Biophytis, said: "We aim to accelerate the availability of Sarconeos (BIO101) to hospitalized patients in France with severe forms of COVID-19 through an early access program that we will present to the HAS in the coming weeks. Sarconeos (BIO101) is a drug candidate that has been shown in the positive phase 2-3 COVA clinical trial to reduce the risk of respiratory failure and early death in these patients by 44%. We plan to file the application formally shortly after with the objective of obtaining approval to start this programme in the second quarter of 2023. In parallel, we are also preparing a conditional approval application due to the health emergency in Europe and the US."
The early access in France is granted by the HAS after the National Agency for the Safety of Medicines and Health Products (ANSM) has given its opinion on the presumption of efficacy and safety. This is a system that allows the provision and early financial coverage, on an exceptional and derogatory basis, of certain medicinal products that meet an unmet medical need, that are likely to be innovative but have not yet been authorised in a therapeutic indication.
About BIOPHYTIS
Biophytis SA is a clinical stage biotechnology company focused on the development of therapeutics aimed at slowing the degenerative processes associated with aging and improving functional outcomes in patients suffering from age-related diseases, including severe respiratory failure in patients with COVID-19. Sarconeos (BIO101), our lead drug candidate, is a small molecule, orally administered drug that is planned to be developed as a treatment for sarcopenia in upcoming Phase 3 clinical trials in the US, Brazil and Europe (SARA-31 and SARA-32). It has also been studied in a two-part Phase 2-3 clinical trial (COVA) for the treatment of severe respiratory manifestations of COVID-19 in Europe, Latin America and the US. A paediatric formulation of Sarconeos (BIO101) is being developed for the treatment of Duchenne muscular dystrophy (DMD). The company is based in Paris, France and Cambridge, Massachusetts. The Company's ordinary shares are listed on Euronext Growth (Ticker: ALBPS -ISIN: FR0012816825) and the American Depositary Shares (ADS) are listed on the Nasdaq Capital Market (Ticker BPTS - ISIN: US09076G1040). For more information, visit www.biophytis.com
Disclaimer
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SOURCE: Biophytis
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