FDA expands indication for Eliquis to treatment of DVT and PE

US pharma majors Bristol-Myers Squibb (NYSE: BMY) and Pfizer (NYSE: PFE) late yesterday said that the US Food and Drug Administration has approved a supplemental New Drug Application for their oral anticoagulant drug Eliquis (apixaban).

The FDA cleared use of the drug for the treatment of deep vein thrombosis (DVT) and pulmonary embolism (PE), and for the reduction in the risk of recurrent DVT and PE following initial therapy. Combined, DVT and PE are known as VTE. It is estimated that every year, around 900,000 Americans are affected by DVT and PE.

Eliquis is the third of three of the new oral anticoagulants to gain approval for DVT, joining Boehringer Ingelheim’s Pradaxa (dabigatran) and Bayer’s Xarelto (rivaroxaban). The added indication for Eliquis is still under review by the European Medicines Agency, whose Committee for Medicinal Products for Human Use (CHMP) has recommended that it be granted. B-MS’ worldwide sales of the drug reached just $171 million for the second quarter of 2014, and it is hoped that the added indication will improve this.