Amicus Therapeutics’ Pombiliti (cipaglucosidase alfa-atga) + Opfolda Receive the US FDA’s Approval for Pompe Disease
Shots:
- The US FDA has approved Pombiliti + Opfolda (65mg) for adults with LOPD who are not improving on their current enzyme replacement therapy. The approval was based on the P-III study (PROPEL) evaluating Pombiliti + Opfolda in ERT-experienced participants in a controlled setting
- Pombiliti + Opfolda is expected to be available in the US shortly & received BTD from the US FDA. The combination therapy was also approved for adults with LOPD in the EU & UK
- The company also provides a patient support program i.e., Amicus Assist which provides access to patients to use the treatment along with identifying possible sources of financial assistance
Ref: Amicus Therapeutics | Image: Amicus Therapeutics
Related News:- Amicus Therapeutics Acquires Celenex for its Ten Gene Therapy Programs
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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.
