The results of the MOVE clinical trial of palovarotene (Sohonos®) in fibrodysplasia ossificans progressiva (FOP), published in December 2022, did not convince the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) They showed :
- in 97 people with PFO, a 62% reduction in the mean annualised volume of heterotopic ossification compared to what was observed in a natural history study involving 114 participants
- a 23.5% risk of early conjugation cartilage fusion in young people under 18 years of age, a known side effect of retinoids, which peaks between the ages of 8 and 10, affecting 58.3% of young people in this age group.
In its press release of 27 January 2023, Ipsen assures that it “will seek a review of the CHMP opinion, based on scientific data from the existing palovarotene clinical trial programme“.
Sohonos® has been approved for the treatment of FOP in Canada since January 2022. Its application for marketing authorisation in the United States is still pending with the Food and Drug Administration (FDA).
Sohonos (palovarotene). European Medicines Agency [Online] [consulted on 30/01/2023]
« Ipsen reçoit une lettre de réponse complète pour le palovarotène, traitement expérimental de la fibrodysplasie ossifiante progressive » Ipsen, December 23, 2022 press release
