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A committee of the European Medicines Agency (EMA) rejected the Ipsen’s recommendation (OTCPK: IPSEY) (OTCPK:IPSEF) the drug palovarotene is approved in the EU for the treatment of a rare bone disorder.
The EMA’s Committee on Medicines for Human Use (CHMP) has recommended not to authorize marketing to palovarotene for the treatment of progressive osteosarcoma (FOP).
FOP is characterized by abnormal bone growth in areas of the body where bone is not normally present. Skeletal muscle and connective tissue, such as tendons and ligaments, are gradually replaced by bone, forming bone outside the skeleton that restricts movement.
The French drugmaker said it would request a re-examination of the opinion of the CHMP, based on available scientific data from an existing palovarotene clinical trial program.
CHMP’s decision is supported by data from a phase 3 trial called MOVE.
“We continue to work closely with the EMA to address the lingering concerns that led to today’s decision, with the goal of making this experimental drug available to appropriate patients, living with the disease.” this debilitating condition, where there are no other treatment options.” speak Howard Mayer, executive vice president and head of R&D at Ipsen.
In December 2022, the US FDA has decline approved palovarotene for the treatment of FOP.
