IPSEY - Ipsen faces another setback for bone disorder drug with EMA panel's rejection

A committee of the European Medicines Agency (EMA) declined to recommended Ipsen's ( OTCPK:IPSEY ) ( OTCPK:IPSEF )  drug palovarotene to treat a rare bone disorder.

The EMA's Committee for Medicinal Products for Human Use (CHMP) recommended not to grant marketing authorization to palovarotene to treat fibrodysplasia ossificans progressiva (FOP).

FOP is characterized by the abnormal development of bone in areas of the body where bone is not usually present. The skeletal muscle and connective tissue, such as tendons and ligaments, are gradually replaced by bone, forming bones outside the skeleton which restrict movement.

The French drugmaker said it will request a re-examination of the CHMP opinion, based on scientific data available from the existing palovarotene clinical trial program.

The CHMP decision was backed by data from a phase 3 trial called MOVE.

"We continue to work closely with the EMA to address the outstanding concerns that led to the decision today, with the goal of making this investigational medicine available to appropriate patients, living with this debilitating disease, where no other treatment option exists," said Howard Mayer, executive vice president and head of Research and Development for Ipsen.

In December 2022, the U.S. FDA had declined to approve palovarotene to treat FOP.

For further details see: