Bristol-Myers Squibb and Japanese partner Otsuka Pharmaceutical Co have won approval from regulators in the USA to market Abilify as a treatment for adolescent schizophrenia sufferers.
The US Food and Drug Administration has given the green light to a supplemental New Drug Application for Abilify (aripiprazole) for the treatment of schizophrenia in adolescents aged 13-17 years. The agency, which first approved the drug for adults in November 2002, is expanding use of the drug based on results from a six-week, randomised, double-blind, placebo-controlled study that demonstrated significant improvement with Abilify compared to placebo.
The new approval for Abilify, an atypical antipsychotic which had third-quarter sales of $420 million, up 34%, comes a few months after the FDA gave the green light to Johnson & Johnson’s rival product Risperdal (risperidone) for adolescents ages 13-17, and also approved the latter to treat bipolar disorder for children between 10 and 17.
Prescriptions of antipsychotics for teenagers have been written mostly ‘off-label’, but getting actual FDA approval means that B-MS can start actively promoting Abilify for the new indication. Next to get approval could be Eli Lilly’s Zyprexa (olanzapine) which is also seeking marketing authorisation for the drug in younger patients.
There have been concerns about the safety profile of antipsychotics but the FDA has said that it feels the benefits outweigh the risks though it will be keeping a close eye on post-marketing data.
