Novartis, Genentech: FDA to Review Xolair Self-Administration Option
August 13 2020 - 10:04AM
Dow Jones News
By Colin Kellaher
Novartis AG and Roche Holding AG's Genentech unit on Thursday
said the U.S. Food and Drug Administration accepted their
application for a self-administration option for the asthma and
allergy drug Xolair.
The companies said they expect a decision by the first quarter
of 2021, adding that approval would make Xolair prefilled syringes
available for either self-administration by select patients or
administration by their caregivers.
Xolair is currently approved in the U.S. for administration by a
healthcare provider in a healthcare setting for patients with
moderate to severe persistent allergic asthma and chronic
idiopathic urticaria, or hives.
Genentech said the Covid-19 pandemic has created an urgent need
for the Xolair self-administration option, particularly for
patients considered high-risk for severe illness.
Novartis and Genentech, which develop and co-promote Xolair in
the U.S., said about 460,000 patients have been treated with the
drug in the country since its initial approval for allergic asthma
in 2003.
The European Commission approved Xolair self-administration in
December 2018.
Write to Colin Kellaher at colin.kellaher@wsj.com
(END) Dow Jones Newswires
August 13, 2020 09:49 ET (13:49 GMT)
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