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Rapid US FDA Review For Roche’s SMA Contender

Physicians Keen On Oral Formulation

 
• By Andrew McConaghie

Roche files quickly to keep up with Novartis’s gene therapy Zolgensma.

Roche_HQ
Roche wants to reach the market early to compete with rivals Novartis

Roche has been granted a priority review in the US for risdiplam, which could challenge or be used alongside Biogen’s Spinraza and Novartis’ Zolgensma in spinal muscular atrophy (SMA), thanks especially to its oral formulation.

The US Food and Drug Administration is expected to make a decision by 24 May 2020, and a rapid approval would help Roche compete with the two

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