FDA approves Otsuka and Lundbeck's once-monthly Abilify Maintena for schizophrenia

Japanese drugmaker Otsuka Pharmaceutical (TYO: 4578) and Danish partner Lundbeck (LUND: DC) have received approval from the US Food and Drug Administration Abilify Maintena (aripiprazole) for extended-release injectable suspension, an intramuscular (IM) depot formulation indicated for the treatment of schizophrenia.

Abilify Maintena is the first dopamine D2 partial agonist approved as a once-monthly injection. It contributes a new treatment option to address the on-going need for relapse prevention in patients with schizophrenia, a chronic, debilitating disease. Lundbeck; shares advanced as much as 3.8%, and rose 3.2% to 99.90 Danish kroner in Copenhagen on Friday morning, as the news came along side European approval for the company’s alcohol addiction drug Selincro (nalmefene; The Pharma Letter March 1).

Abilify Maintena will be the first commercialized product from the long-term global alliance between Otsuka and Lundbeck to develop CNS medicines worldwide. The companies expect the product will start becoming available in the US beginning March 18. The once daily Abilify treatment generated sales of $2.8 billion in 2012 sales for Otsuka’s partner Bristol-Myers Squibb (NYSE: BMY).