It’s the latest twist in the turbulent tale of the ultra-rare disease therapy – developed to treat genetic disorder fibrodysplasia ossificans progressiva (FOP) – which has seen progress to the US market held up by a series of clinical and regulatory obstacles.
In the latest setback, a 31 October Endocrinologic and Metabolic Drugs Advisory Committee meeting has been cancelled and postponed to a later, undecided date, giving the FDA time to see data from a clinical trial that, according to the French drugmaker, “does not relate to the safety profile of palovarotene”.
