Roche: FDA Delays Decision on Risdiplam Drug
April 08 2020 - 1:45AM
Dow Jones News
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
(END) Dow Jones Newswires
April 08, 2020 01:30 ET (05:30 GMT)
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