Genentech Gets FDA Priority Review for Risdiplam for Spinal Muscular Atrophy
November 25 2019 - 7:36AM
Dow Jones News
By Colin Kellaher
Roche Holding AG's (ROG.EB) Genentech unit on Monday said the
U.S. Food and Drug Administration accepted for priority review the
company's new drug application for risdiplam for spinal muscular
atrophy, or SMA.
Genentech said risdiplam, if approved, would be the first
at-home administered medicine for people living with spinal SMA, an
inherited, progressive neuromuscular disease.
The FDA grants priority review to medicines that have the
potential to provide significant improvements in the treatment of a
serious disease, and the designation shortens the review period to
six months from the standard 10 months.
Genentech said the agency set a target action date of May 24,
2020.
PTC Therapeutics Inc. (PTCT), which initiated an SMA in
partnership with the SMA Foundation in 2006, said the FDA'a
acceptance of the filing triggers a $15 million milestone payment
to the company from Roche under a 2011 licensing deal.
Genentech would commercialize risdiplam in the U.S. upon FDA
approval.
Write to Colin Kellaher at colin.kellaher@wsj.com
(END) Dow Jones Newswires
November 25, 2019 07:21 ET (12:21 GMT)
Copyright (c) 2019 Dow Jones & Company, Inc.
Roche (QX) (USOTC:RHHBY)
Historical Stock Chart
From Mar 2024 to Apr 2024
Roche (QX) (USOTC:RHHBY)
Historical Stock Chart
From Apr 2023 to Apr 2024
