Better late than never, Bristol-Myers Squibb might say. In a move that's sure to incite debate, the FDA says it will allow BMS to market its schizophrenia med Abilify for use in adolescents.
The agency had accepted Bristol's app to expand indications for the drug back in June, giving it priority review. But the fast track couldn't have been fast enough to deter a federal prosecutor who'd been pursuing civil penalties against the company, in part for marketing Abilify to children. Bristol settled with U.S. Attorney Michael Sullivan in September, agreeing to pay $515 million to nullify a variety of fraudulent marketing and pricing claims.
Despite concern over the long-term side effects of atypical antipsychotics, such as weight gain leading to diabetes, Abilify is the second drug in this class to get FDA approval for adolescent use this year. Johnson & Johnson won the FDA's blessing for Risperdal in August, without having to submit to an advisory committee debate over its safety and efficacy. Eli Lilly's Zyprexa is next in the approval line. You'll recall, though, that Lilly last month added new warnings to Zyprexa's label, citing the drug's tendency to cause high blood sugar and cholesterol, weight gain, and other metabolic problems.