Bristol's Abilify gets nod for adolescents

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.

- see BMS's release
- take a look at the CNN Money report
- read background on the fraud settlement in the Boston Globe
- read about Zyprexa's new warnings in The New York Times

Suggested Articles

Pfizer's diagnosis-focused launch strategy for Vyndaqel and Vyndamax is paying off with the meds reaching thousands of patients already.

Pfizer terminated a slew of trial cohorts testing Bavencio in combination with its own experimental drugs, as well as one monotherapy trial.

With its Eli Lilly-partnered Olumiant nearing filing in atopic dermatitis, Incyte's other JAK med Jakafi is also looking for a win in that indication.