Inventiva receives positive opinion on orphan drug designation in the European Union for IVA337 - a treatment for Systemic Sclerosis (SSc)

04-Nov-2014 - France

Inventiva, a drug discovery company that focuses on therapeutic approaches involving transcription factors and epigenetic targets, announced that the Committee for Orphan Medicinal Products (COMP) at the European Medicines Agency (EMA) has given a positive opinion on the designation of IVA337 as an  orphan medicinal product.IVA337 is Inventiva’s lead clinical candidate for the treatment of systemic sclerosis (SSc).

This positive COMP opinion is a key milestone in our clinical development plan for IVA337,” said Pierre Broqua, chief scientific officer and co-founder of Inventiva. “Our clinical candidate acts on several components of fibrosis to deliver a unique therapeutic approach to SSc patients.”
IVA337 is a patent protected NCE (New Chemical Entity) that has previously demonstrated good tolerability, safety and efficacy in phase 1 and 2 studies in an unrelated indication. IVA337 has been investigated in several preclinical models of fibrotic disorders and reverses established skin fibrosis in curative settings.

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