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Novartis’s Zolgensma Loses EU Accelerated Assessment

 
• By Alexandra Shimmings

Companies pleased at gaining an EU accelerated assessment for a product should be aware that the agency offers no guarantee that they will get to keep it. Novartis’s Zolgensma is one of seven drugs whose review the EMA has taken off the fast track.

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Speed restrictions applied in Europe for Zolgensma • Source: Shutterstock

The EU review for Novartis AG/AveXis Inc.’s novel gene therapy Zolgensma is now going at a more sedate pace after the European Medicines Agency reverted its initial accelerated assessment to a standard review.

It is among seven products whose MAAs (marketing authorisation applications) were originally granted an accelerated assessment that are no longer...

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