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.
The Phase 3 study was a randomized, double-blind, non-inferiority trial including 702 adults with schizophrenia.
The drug won FDA approval in September, but its trade name in the U.S. is Invega Hafyera.
To be eligible for the drug, patients must be clinically stable on either once-monthly paliperidone palmitate (PP1M) or three-monthly paliperidone palmitate (PP3M).
Janssen formulated the drug to have exceptionally low water solubility, enabling it to offer continuous absorption over six months.