FDA Approves Ipsen’s Ultra-Rare Bone Disease Drug Sohonos

August 17, 2023

The Food and Drug Administration (FDA) has approved Ipsen Pharmaceuticals’ Sohonos, a drug designed to treat fibrodysplasia ossificans progressiva (FOP), an ultra-rare bone disease. The drug reduces undesired bone formation in soft tissues and is slated for use in females over eight and males over 10 with FOP. This approval followed a successful 18-month Phase 3 trial, revealing the drug’s efficacy at reducing bone volume and demonstrating a sound safety profile. However, despite backing from the Endocrinologic and Metabolic Drugs Advisory Committee, the European Medicine Agency did not approve Sohonos. Additionally, following a solid first half-year in sales, Ipsen revised its financial guidance upward and announced the acquisition of Albireo Pharma for $952 million, which includes the approved liver disease drug Bylvay.

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[Source: MM+M, August 17th, 2023]

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