Bristol-Myers Squibb and Pfizer granted CHMP backing for AF drug

Bristol-Myers Squibb and Pfizer have been granted a Committee for Medicinal Products for Human Use (CHMP) recommendation for European approval of the drug Eliquis, based on strong clinical trial data.

The European Medicines Agency committee has produced a positive opinion on the drug's use for the prevention of stroke and systemic embolism in adult patients with non-valvular atrial fibrillation (AF) and one or more risk factors for stroke.

Results from the pivotal Aristotle and Averroes studies have demonstrated the strong performance of the drug among 24,000 patients, making this the largest clinical trial programme ever conducted among this group.

The recommendation will now be reviewed by the European Commission ahead of its final approval decision, which follows the CHMP's opinion in the majority of cases.

Last week, it was announced that Bristol-Myers Squibb and Pfizer will be allying with eight other pharmaceutical companies to form TransCelerate BioPharma, a joint initiative aimed at accelerating the drug development process.