Amicus Therapeutics’ Pombiliti (cipaglucosidase alfa-atga) + Opfolda Receive the US FDA’s Approval for Pompe Disease
- 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
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