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April 8, 2020, 1:23 a.m. EDT

Roche: FDA delays decision on risdiplam drug

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By Olivia Bugault

Roche Holding AG said late Tuesday that the U.S. Food and Drug Administration has extended its review of risdiplam, an experimental drug for the treatment of spinal muscular atrophy.

The Swiss pharmaceutical giant said the FDA decision is now expected by the end of August, compared with May 24 previously.

"The extension is a result of the recent submission of additional data by Roche, including data from the pivotal Sunfish Part 2 study," it said, adding that the data "could help ensure access to risdiplam for a broad range of people living with the condition, if approved."

Roche has also submitted filing applications in seven other countries for risdiplam, including in Brazil, Chile and South Korea, while a submission in China is imminent, it said.

Write to Olivia Bugault at olivia.bugault@wsj.com

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