J&J's Janssen Gets CHMP Backing for Twice-Yearly Schizophrenia Treatment

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 [e-mail]

(END) Dow Jones Newswires

09-17-21 0806ET