Two months after receiving a positive opinion from the Committee for Medicinal Products for Human Use (CHMP), Janssen has won approval from the European Commission for Byannli, a six-month formulation of paliperidone palmitate.
Indicated as a maintenance treatment for adults with schizophrenia, Byannli won approval based on results from the Route 6 study, which found that 92.5% of patients receiving the therapy were relapse-free at 12 months.
Get the full story from our sister site, Drug Discovery & Development.
