FDA approves Lundbeck and Otsuka's Rexulti for MDD and schizophrenia

The US Food and Drug Administration has approved Rexulti (brexpiprazole), from Japanese drugmaker Otsuka (TYO: 4768) and Danish CNS specialist Lundbeck (LUND: CO), as an adjunctive therapy for the treatment of adults with major depressive disorder (MDD) and as a treatment for adults with schizophrenia.

Rexulti was discovered by Otsuka and co-developed with Lundbeck. It will be co-marketed by the two companies and is expected to become available to patients in the US in early August 2015. Brexpiprazole is considered as a successor to Otsuka’s Abilify (aripiprazole), which faced patent expiration in April 2015.

Reacting to the news announced on Saturday, Otsuka’s shares gained 2.3% to 6,200.00 yen by mid-afternoon in Tokyo trading today, while Lundbeck gained 5.7% to 152.60 Danish kroner shortly after the Copenhagen market opened this morning.