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Ipsen Receives CHMP Negative Opinion for Palovarotene to Treat Fibrodysplasia Ossificans Progressiva

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Ipsen Receives CHMP Negative Opinion for Palovarotene to Treat Fibrodysplasia Ossificans Progressiva

Shots:

  • Followed by the negative opinion, Ipsen will be requesting a re-examination of the CHMP opinion, based on existing data of palovarotene clinical trial program (MOVE)
  • The CHMP opinion is based on the data of the P-III study (MOVE, NCT03312634), evaluated the efficacy and safety of palovarotene (5mg, QD, oral) and episodic (20mg, QD for 4wks., followed by 10mg for ≥8wks, for flare-ups and trauma) in patients (n=107) with FOP
  • 1EPs were to evaluate the safety and efficacy of palovarotene in reducing new HO volume, as measured by whole-body CT vs patients untreated beyond SoC from Ipsen’s global FOP natural history study

Ref: BusinessWire Image: Ipsen 

Related News:- Ipsen Presents P-III Trial (NAPOLI 3) Results of Onivyde for Metastatic Pancreatic Ductal Adenocarcinoma at ASCO GI 2023

Click here to­ read the full press release 

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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.

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