BioCentury
ARTICLE | Product Development

May 21 Quick Takes: EC approves Zolgensma for SMA; plus Sunovion, Kadmon, Sorrento, tafasitamab, Zentalis’ new JV

May 22, 2020 1:47 AM UTC

Immediate access to Zolgensma in France
The European Commission conditionally approved Zolgensma onasemnogene abeparvovec from Novartis AG (NYSE:NVS; SIX:NOVN) to treat spinal muscular atrophy in babies and young children who have SMA Type 1 or up to three copies of the SMN2 gene. The company is offering the gene therapy via its Day One access program to ensure patient access before national pricing and reimbursement agreements are in place; the program offers retroactive and outcomes-based rebates, as well as deferred and installment payment options. Zolgensma, which gained the recommendation of EMA’s CHMP in March and is approved in the U.S. and Japan, will be immediately available in France, with access expected soon in Germany.

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