AbbVie to Seek FDA Nod for Vraylar as Adjunct Treatment for Major Depressive Disorder
October 29 2021 - 8:54AM
Dow Jones News
By Colin Kellaher
AbbVie Inc. on Friday said a Phase 3 study of its antipsychotic
drug Vraylar as an adjunctive treatment for major depressive
disorder met its primary endpoint, and that it plans to seek
expanded approval in the indication from the U.S. Food and Drug
Administration.
The North Chicago, Ill., biopharmaceutical company said Vraylar
showed a statistically significant change from baseline to week six
compared with placebo in patients with major depressive
disorder.
AbbVie noted that Vraylar showed numerical improvement in
depressive symptoms from baseline to week six in a second Phase 3
study but didn't achieve statistical significance.
However, the company said that based on the positive results of
the first study and an earlier Phase 2/3 registration-enabling
trial, along with the totality of data reported, it plans to seek
FDA approval for the expanded use of the drug for the adjunctive
treatment of major depressive disorder.
The FDA has previously approved Vraylar to treat depressive,
acute manic and mixed episodes associated with bipolar I disorder,
as well as schizophrenia in adults.
AbbVie, which is developing Vraylar jointly with Hungary's
Gedeomn Richter PLC, is responsible for commercialization in the
U.S., Canada, Japan, Taiwan and certain Latin American
countries.
Write to Colin Kellaher at colin.kellaher@wsj.com
(END) Dow Jones Newswires
October 29, 2021 08:39 ET (12:39 GMT)
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