Otsuka and Lundbeck’s Schizophrenia/ Depression Drug Secures FDA Approval

Otsuka and H. Lundbeck expect to launch once-daily Rexulti as a treatment for schizophrenia and add-on therapy for major depressive disorder in early August, following FDA approval last week.

The companies will try to position Rexulti as a better, branded alternative to generic versions of Otsuka’s blockbuster antipsychotic drug Abilify.

The approval — which includes a boxed warning on the label — was supported by four placebo-controlled Phase III trials, two for each indication.

There are about 15 million adults in the U.S. with major depressive disorder, many of whom have an inadequate response to single therapies, Otsuka says.

Alembic Pharmaceuticals, Hetero Labs, Teva and Torrent Pharmaceuticals all have approved generics of Abilify. Otsuka lost a suit against the FDA in May in which it claimed the agency knowingly removed its monopoly protection by extending Abilify’s pediatric indication for Tourette syndrome to adults, which the company had not sought.

Rexulti was discovered by Otsuka and co-developed with Lundbeck. The two companies will co-market the drug.

The approval comes on the heels of Janssen Pharmaceuticals’ June launch of its long-lasting schizophrenia injectable Invega Trinza, following FDA approval in May. — Kellen Owings