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Roche: FDA Extends Review Time For SMA Drug Risdiplam

Swiss drug maker Roche Group (RHHBY) announced Wednesday that the U.S. Food and Drug Administration has extended the review time for risdiplam for the treatment of spinal muscular atrophy or SMA.

In a statement, the company noted that the Prescription Drug User Fee Act or PDUFA date for FDA's review of the New Drug Application of risdiplam has been extended with a decision expected by August 24.

The extension is a result of the recent submission of additional data by Roche, including data from the pivotal SUNFISH Part 2 study, in close collaboration with the FDA.

In November 2019, the FDA granted Priority Review for risdiplam with a decision for approval expected by May 24. In February 2020, based on discussions with the FDA, Roche submitted additional data which could help ensure access to risdiplam for a broad range of people living with the condition, if approved. The FDA requires more time for review due to the volume of additional data submitted.

Roche has submitted filing applications for risdiplam in seven countries with submission in China imminent. Risdiplam is being investigated in infants, children and adults with Type 1, 2 or 3 SMA.

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