(Boursier.com) — The European Commission (EC) has decided to follow the recommendations issued by the CHMP in May this year. It therefore did not grant marketing authorization for palovarotene, an experimental drug for the treatment of fibrodysplasia ossificans progressiva (FOP). Palovarotene is the first drug to be submitted to regulatory authorities worldwide for the treatment of FOP, an ultra-rare disease with approximately 900 known cases worldwide.
Ipsen plans to pursue its regulatory approval applications in other countries and regions.
“We are working hard to provide FOP patients in the EU with a much needed treatment option,” said Howard Mayer, Executive Vice President, Head of Research and Development at Ipsen. “We are confident that our clinical data provide evidence of the effect of palovarotene in reducing the abnormal formation of new bone material, known as heterotopic ossification, which characterizes the disease. We are therefore disappointed that the European Commission has decided not to approve this treatment for patients with FOP in Europe. patients with the disease or the doctors and healthcare professionals who manage their care. It is also thanks to their commitment that we have decided to pursue applications for approval from other regulatory authorities”.
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