Roche's Xolair Granted FDA Priority Review
2023年12月20日 - 12:27AM
Dow Jones News
By Mauro Orru
Roche Holding's Xolair antibody received priority review
treatment from the Food and Drug Administration after a late-stage
study yielded positive results that the company said could make
Xolair the first medicine to reduce allergic reactions to multiple
foods.
The Swiss pharmaceutical company said Tuesday that the FDA
should make a decision on approval in the first quarter of the new
year, after positive results from a phase 3 study assessing Xolair
in patients allergic to peanuts and at least two other common
foods.
"Despite the significant and growing health burden from food
allergies, treatment advances have been limited," said Levi
Garraway, Roche's Chief Medical Officer and Head of Global Product
Development. "The FDA's priority review designation acknowledges
the unmet need for these patients, and we hope to make Xolair
available to as many people as possible living with food allergies
in the U.S."
Write to Mauro Orru at mauro.orru@wsj.com
(END) Dow Jones Newswires
December 19, 2023 10:12 ET (15:12 GMT)
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