(Reuters) – French drugmaker Ipsen said on Wednesday the European Commission has not granted marketing authorization for palovarotene, an investigational treatment for fibrodysplasia ossificans progressiva (FOP), a condition that causes abnormal bone growth.
The decision follows a negative opinion issued in May by the European Medicines Agency’s Committee for Medicinal Products for Human Use (CHMP), the company said in a statement.
The French pharmaceutical group added that it will continue seeking regulatory approvals in other countries and regions.
FOP is a rare condition with about 900 known cases worldwide. It causes muscle tissues to turn into bones, resulting in a progressive mobility loss and reduced life expectancy.
In June, Ipsen said the U.S. Food and Drug Administration’s Endocrinologic and Metabolic Drugs Advisory Committee had voted in favor of palovarotene as an effective treatment for FOP.
There is currently no approved treatment options available in the European Union for FOP.
(Reporting by Dina Kartit; Editing by Mike Harrison)
