Inventiva receives FDA Fast Track designation in MPS VI for its clinical-stage asset odiparci
- The designation is intended to accelerate the regulatory review and facilitate the overall development of odiparcil for the treatment of MPS VI patients
Daix (France), October 19, 2020 – Inventiva (Euronext Paris and Nasdaq: IVA), a clinical-stage biopharmaceutical company focused on the development of oral small molecule therapies for the treatment of non-alcoholic steatohepatitis (NASH), mucopolysaccharidoses (MPS) and other diseases with significant unmet medical need, today announced that the U.S. Food and Drug Administration (FDA) has granted Fast Track designation to odiparcil, the Company’s clinical-stage drug candidate for the treatment of MPS type VI (MPS VI), a rare and progressive genetic disorder.
The Fast Track program of the FDA is designed to facilitate the development and expedite the regulatory review and potential approval of drug candidates. Its overall objective is to improve patient access to therapies aimed at treating serious conditions and filling significant unmet medical needs.
Pierre Broqua, Ph.D., Chief Scientific Officer and cofounder of Inventiva, commented: “We are very pleased by the FDA’s decision to grant Fast Track designation to odiparcil for the treatment of MPS VI. It is a clear recognition of the existing unmet medical need for this rare and progressive genetic disorder. We believe that odiparcil has the potential to become a treatment of choice for MPS VI patients, especially due to its oral formulation and ability to reach organs and tissues which are poorly treated by the current standard of care. This designation represents an important step in the development of odiparcil towards becoming an additional treatment for MPS VI patients, who are looking for more efficacious and convenient therapies.”
Fast Track designation offers the possibility of more frequent communication with the FDA to discuss the drug candidate’s development plan, the design of the proposed clinical trials, the use of biomarkers, and the collection of appropriate data required to support drug approval. It also offers access to accelerated approval and priority review, as well as to rolling review of its Biologic License Application (BLA) or New Drug Application (NDA) on a section by section basis, rather than waiting for the entire BLA or NDA to be completed.