Roche's Genentech Gets FDA Priority Review for Flu Drug
June 26 2018 - 6:38AM
Dow Jones News
By Colin Kellaher
Roche Holding AG's (ROG.EB) Genentech unit on Tuesday said the
U.S. Food and Drug Administration accepted and granted priority
review to a New Drug Application for baloxavir marboxil as a
single-dose, oral treatment for acute, uncomplicated influenza in
people 12 years and older.
If approved, baloxavir marboxil would be the first oral,
single-dose antiviral and the first medicine with a novel proposed
mechanism of action to treat the flu in nearly 20 years, Genentech
said.
The drug maker said the FDA is expected to make a decision on
approval by Dec. 24, 2018. The FDA grants a priority-review
designation to medicines the agency believes have the potential to
provide significant improvements in the treatment, prevention or
diagnosis of a disease.
Genentech said baloxavir marboxil has been shown in clinical
trials to reduce the duration of flu symptoms with one dose and
demonstrated a significant reduction in viral shedding in one
day.
Genentech said flu epidemics result in 3 million to 5 million
cases of severe disease, millions of hospitalizations and up to
650,000 deaths worldwide each year.
Baloxavir marboxil was discovered by Shionogi & Co.
(4507.TO), which is developing the drug globally with Roche. Roche
holds worldwide rights to baloxavir marboxil, excluding Japan and
Taiwan, which are retained exclusively by Shionogi.
Write to Colin Kellaher at colin.kellaher@wsj.com
(END) Dow Jones Newswires
June 26, 2018 06:23 ET (10:23 GMT)
Copyright (c) 2018 Dow Jones & Company, Inc.
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