Shots:
- The US FDA has awarded priority review voucher & approved Miplyffa (47mg to 124mg, oral, TID) + miglustat to treat neurological manifestations in adults & pediatrics (≥2yrs.) with NPC, with its launch planned within 8-12wks.
- Approval was based on trial of Miplyffa + miglustat vs PBO in NPC patients (2-19yrs.), showing halted disease progression with 0.2 vs 1.9-point reduction at 12mos. Data from a 48mos. OLE trial provided additional evidence of improved outcomes
- Zevra has launched AmplifyAssist, offering insurance education, copay assistance, disease information, therapy management counseling & support for prescription refills for the eligible patients in need
Ref: GlobeNewswire | Image: Zevra Therapeutics | Press Release
Related News:- Roche Reports the US FDA’s Approval of Ocrevus Zunovo for Treating Relapse and Progressive Multiple Sclerosis
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