Genentech Gets FDA Priority Review For Rituxan in Children With Rare Blood Vessel Disorders
June 12 2019 - 6:48AM
Dow Jones News
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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