The week in pharma: action, reaction and insight – week to May 26, 2023

By Barbara Obstoj-Cardwell. Editor

On the regulatory front, a US Food and Drug Administration (FDA) advisory committee last week came down heavily against approval of Intercept Pharmaceuticals’ obeticholic acid (OCA) as a treatment for pre-clinical cirrhotic liver fibrosis due to non-alcoholic steatohepatitis (NASH). Meantime, US biotech Blueprint Medicines announced that the FDA has approved its drug Ayvakit for the all-important indication of indolent systemic mastocytosis. M&A news included gastrointestinal specialist Ironwood Pharmaceuticals agreeing to buy Swiss firm VectivBio, along with its short bowel syndrome drug apraglutide, for $1 billion. Mirati Therapeutics announced that its sitravatinib, in combination with Opdivo, had failed to meet the primary endpoint of a clinical trial in lung cancer, and it would therefore abandon further development.

Key readthroughs from OCA AdCom to the NASH field