Genentech Gets FDA Priority Review for Risdiplam for Spinal Muscular Atrophy

Date : 11/25/2019 @ 12:36PM
Source : Dow Jones News
Stock : Roche Holding (QX) (RHHBY)
Quote : 38.395  -0.175 (-0.45%) @ 10:20PM
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Genentech Gets FDA Priority Review for Risdiplam for Spinal Muscular Atrophy

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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.

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