By Colin Kellaher
Johnson & Johnson's Janssen Pharmaceutical Cos. unit on Friday said the European Medicines Agency's Committee for Medicinal Products for Human Use recommended approval of Byannli, a six-month maintenance treatment of schizophrenia, in adults.
The drug maker said the recommendation, which covers patients who are clinically stable on one-month or three-month treatments, is based on results from a study that showed that 92.5% of patients treated with Byannli were relapse-free at the end of the 12-month double-blind phase.
The European Commission, which generally follows CHMP's advice, would now review the recommendation.
Janssen said approval would make Byannli the first twice-yearly injectable for the treatment of schizophrenia in adults in Europe.
Write to Colin Kellaher at firstname.lastname@example.org
(END) Dow Jones Newswires
September 17, 2021 08:06 ET (12:06 GMT)Copyright (c) 2021 Dow Jones & Company, Inc.