US nod for injectable bipolar drug a welcome boost for Lundbeck

Danish CNS specialist Lundbeck (LUND: CO) and Japan’s Otsuka Pharmaceutical (TYO: 4768) have announced that Abilify Maintena (aripiprazole) for extended-release injectable suspension has been approved by the US Food and Drug Administration (FDA) for the maintenance monotherapy treatment of bipolar I disorder in adults.

It is the first FDA-approved, once-monthly, long-acting injectable for this recurrent chronic mental illness, having been created by Otsuka and co-developed and co-commercialized with Lundbeck. It is also used for schizophrenia.

Joseph Calabrese, director of the Mood Disorders Program at University Hospitals Cleveland Medical Center, USA, said: “Abilify Maintena provides healthcare professionals (HCPs) a new treatment option for their patients who have established tolerability with oral aripiprazole.