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US FDA Puts IT Zolgensma Studies On Partial Clinical Hold

Zolgensma And IV Studies Unaffected

 
• By Alexandra Shimmings

The roller coaster ride for Novartis with its high-profile gene therapy Zolgensma continues as the FDA places a partial hold on trials of an intrathecal version aimed at older SMA patients on the back of nerve inflammation seen in a preclinical study.

Roller coaster
Zolgensma taking Novartis on a wild ride • Source: Shutterstock

A year of highs and lows for Novartis AG’s gene therapy product Zolgensma continues with the US Food and Drug Administration now placing on partial clinical hold studies looking at intrathecal administration of the product following troubling results from an animal study.

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