FDA approves once-monthly Abilify for schizophrenia

Feb 28 (Reuters) - U.S. 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 U.S. 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 healthcare 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.