Genentech Gets FDA Priority Review For Rituxan in Children With Rare Blood Vessel Disorders

Date : 06/12/2019 @ 10:48AM
Source : Dow Jones News
Stock : Roche Holding (QX) (RHHBY)
Quote : 38.04  0.51 (1.36%) @ 7:14PM

Genentech Gets FDA Priority Review For Rituxan in Children With Rare Blood Vessel Disorders

Roche Holding (QX) (USOTC:RHHBY)
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By Colin Kellaher

 

Roche Holding AG's (ROG.EB) Genentech unit Wednesday said the U.S. Food and Drug Administration accepted for priority review the company's supplemental biologics-license application for Rituxan in children with two rare blood vessel disorders.

Genentech said the sBLA covers the use of Rituxan, in combination with glucocorticoids, for the treatment of granulomatosis with polyangiitis and microscopic polyangiitis in children two years of age and older.

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.

The agency approved Rituxan in 2011 for the treatment of adults with two rare forms of vasculitis. Genentech said approval of the sBLA would mark the first pediatric indication for Rituxan.

 

Write to Colin Kellaher at colin.kellaher@wsj.com

 

(END) Dow Jones Newswires

June 12, 2019 06:33 ET (10:33 GMT)

Copyright (c) 2019 Dow Jones & Company, Inc.

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