FDA approves Abilify for schizophrenia

Regulators on Thursday approved a once-monthly injectable form of Abilify, the blockbuster treatment for schizophrenia, which will be sold by Japanese drugmaker Otsuka and Danish drug group Lundbeck.

In July 2012, the Food and Drug Administration declined to approve the medicine, Abilify Maintena, citing deficiencies from an inspection of a third-party supplier of sterile water. Otsuka and Lundbeck resubmitted their marketing application soon afterward, after working with an alternative supplier.

About 1 percent of adults in the United States are believed to have schizophrenia, a disorder of thought processes that can involve hallucinations, delusions and poor emotional responsiveness.

The new formulation of Abilify is meant to provide long-term prevention of relapses from schizophrenia symptoms, particularly for patients who don't faithfully take their anti-psychosis medicines.

But the medicine has a convenience disadvantage. It comes in a "cake" form, which must be diluted with sterile water for injection. That means it has to be given by a health care professional.

For a decade, Otsuka and Bristol-Myers Squibb had co-marketed the once-daily basic formulation of Abilify, which had global sales of $2.8 billion in 2012.

Under an updated partnership agreement, Otsuka early this year began to take on complete marketing responsibility for basic Abilify, but Bristol-Myers will continue to manufacture the medicine and share in revenue from it.