Ipsen has suffered a setback in its marathon effort to bring palovarotene to market for ultra rare disease fibrodysplasia ossificans progressiva (FOP), after EU advisors recommended against
Less than a week before Ipsen's palovarotene was due to go in front of an FDA advisory committee, the meeting has been called off following a request by the regulator for more data.
The EMA's human medicines committee has recommended against approval of Eisai and Biogen's Alzheimer's disease therapy Leqembi, after regulators in the US, China and Japan gave a green ligh