Alkermes to Launch Schizophrenia Drug

Alkermes is preparing to launch its schizophrenia drug Aristada in the U.S. following FDA approval this week — making it the latest generic to threaten Otsuka’s grasp on the multibillion dollar antipsychotics market via Abilify.

An extended-release injectable version of Abilify (aripiprazole lauroxil), Aristada is the first atypical antipsychotic with once-monthly or six-week dosing options, providing certainty that patients with the mental illness receive their medication, the FDA says.

The agency approved the drug based on a Phase 3 study showing significant improvements in schizophrenia symptoms with Aristada versus placebo.

Alembic Pharmaceuticals, Hetero Labs, Teva and Torrent Pharmaceuticals received FDA approval of their generic Abilify versions earlier this year after Otsuka lost a patent protection lawsuit against the FDA. — Jonathon Shacat