Otsuka and Lundbeck receive FDA approval for Rexulti

TOKYO and VALBY, Denmark — Otsuka Pharmaceutical and H. Lundbeck A/S announced Friday that their new medication Rexulti (brexpiprazole) had been approved by the Food and Drug Administration as an adjunctive treatment for major depressive disorder (MDD) and a treatment for schizophrenia. The two companies will co-market the drug, which will be made available in early August. 

“Psychiatric diseases remain a challenging therapeutic area where many people are unsatisfied with their treatments,” Otsuka Pharmaceutical president and representative director Tatsuo Higuchi said. “Today’s approval of Rexulti is another example of Otsuka and Lundbeck’s commitment to bringing new therapeutic alternatives to the mental health community.”

MDD, which affects some 15 million Americans, is particularly severe depression often accompanied with thoughts of suicide, and does not always respond to treatment by antidepressants alone. Schizophrenia affects 2.4 million adults in America.

“All treatment options require healthcare providers, patients and caregivers to balance efficacy and tolerability in managing their diseases,” said Kåre Schultz, President and CEO, Lundbeck. “We are proud to introduce REXULTI to help adult patients living with MDD and schizophrenia.”

The approval for this treatment comes as generics of Otsuka’s Abilify — a treatment for various neurological disorders including schizophrenia — hit the market after its patent expired in April.