Roche: FDA extends review time for SMA treatment

(CercleFinance.com) - Roche said on Wednesday that US health regulators have extended the action date on its experimental treatment of spinal muscular atrophy (SMA) by three months.


The Food and Drug Administration's decision regarding the approval of risdiplam is now expected by 24 August, instead of 24 May, when the FDA granted priority review for the drug last year.

Roche said the extension is a result of the recent submission of additional 12-month data from a pivotal study undertaken in people aged 2-25 years with Type 2 or 3 SMA.

Given the volume of additional data submitted, the FDA needs more time for its review, the Swiss drugmaker said.

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