(AOF) – Inventiva announced that the FDA has completed the safety assessment of the Investigational New Drug (IND) application. The US health authority has concluded that the proof-of-concept phase 2 clinical trial combining its lead drug candidate lanifibranor with empagliflozin, an SGLT2 inhibitor, in patients with type 2 diabetes (T2D) and non-alcoholic steatohepatitis non-cirrhotic (NASH) could continue.
According to Pierre Broqua, Scientific Director and co-founder of Inventiva, this decision by the FDA represents an important step in the development of lanifibranor.
The launch of the study is scheduled for the first half of 2022 and the publication of the first results for the second half of 2023.
LEXICON
FDA (Food and Drug Administration)
Among the attributions of the Food and Drug Administration (the health authorities in the United States) there is in particular the issuance of marketing authorizations for all drugs intended for this country, which represents the world’s largest market for ‘pharmaceutical industry.
Clinical trials (Phases I, II, III)
Phase I: small-scale testing of the molecule on humans to assess its safety, tolerance, metabolic and pharmacological properties. Phase II: evaluation of tolerance and efficacy on several hundred patients to identify side effects. Phase III: assessment of the overall benefit/risk ratio with several thousand patients.
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Boost for French pharmacy
At the end of a recent CSIS, the French authorities announced an amount of credits (7 billion euros) never reached: 1.5 billion for hospital-university research, 2 billion for investment in health via bpi france , 1.5 billion in aid for the relocation of industrial projects, and 2 billion to strengthen investment in three sectors of the future (bioproduction, digital medicine, and pandemic preparedness). In addition, the annual growth in drug expenditure reimbursed by Medicare will be 2.4%, which should generate growth of at least 0.5% in the turnover of laboratories,
Above all, the normal drug marketing procedure will be accelerated (up to 500 days saved) if the medical benefit rendered is sufficient.