Delay to Roche risdiplam review for SMA in USA

8 April 2020

Swiss oncology giant Roche (ROG: SIX) has announced an extension to the US review of its risdiplam New Drug Application (NDA) in spinal muscular atrophy (SMA).

A decision is now expected three months later, by August 24, due to the recent submission of additional data, including data from the pivotal SUNFISH Part II study.

One-year data from SUNFISH Part II showed that change from baseline in a commonly-used motor function scale was significantly greater for the risdiplam group, compared to placebo.

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