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Novartis Wants More Time To Answer EMA’s Zolgensma Questions

 
• By Maureen Kenny

Novartis unit AveXis is one of several companies seeking extra time to address questions the European Medicines Agency has regarding their marketing applications. The company says it could get a decision on whether the product should be approved in the EU by year-end.

Many clocks in a vending machine to illustrate the importance and fleeting nature of time and the desire to buy more and make a moment last longer - Illustration
Extra time is sometimes needed to answer EMA's questions • Source: Shutterstock

Novartis unit AveXis wants more time to respond to questions the European Medicines Agency has regarding its marketing authorization application (MAA) for Zolgensma (onasemnogene abeparvovec), the gene therapy for treating spinal muscular atrophy that is at the heart of a data manipulation controversy in the US.

Zolgensma is at the later stages of review under the centralized procedure at the EMA. Novartis AG said it...

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• By Jessica Merrill and Bridget Silverman

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