Ipsen’s Sohonos (palovarotene) Receives the US FDA’s Approval for Fibrodysplasia Ossificans Progressiva
Shots:
- The US FDA has approved Sohonos for adults & pediatric patients aged ≥8yrs. for females and ≥10yrs. for males with FOP. The capsules are indicated for the reduction in volume of new heterotopic ossification
- The approval was based on the P-III trial (MOVE) trial which showed a reduction in an annualized heterotopic ossification volume, a 54% reduction with a weighted linear mixed effect model. Palovarotene has a well-characterized safety profile with AEs consistent with the systemic retinoid class
- The 18mos. results were published in the Journal of Bone and Mineral Research. Ipsen Cares patient support program provides educational support, addresses coverage, access & reimbursement questions, also provides treatment access to eligible individuals in the US
Ref: Ipsen | Image: Ipsen
Related News:- Ipsen Receives CHMP Negative Opinion for Palovarotene to Treat Fibrodysplasia Ossificans Progressiva
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Neha is a Senior Editor at PharmaShots. She is passionate and very enthusiastic about recent updates and developments in the life sciences and pharma industry. She covers Biopharma, MedTech, and Digital health segments along with different reports at PharmaShots. She can be contacted at connect@pharmashots.com.
