FDA Approves Eliquis sNDA

The FDA has approved an expanded indication for Bristol-Myers Squibb and Pfizer’s blood thinner Eliquis as a treatment to prevent potential deep vein thrombosis (DVT) in patients who have had hip or knee replacement surgery.

Eliquis (apixaban) is already approved as a prophylaxis to reduce risk of stroke and systemic embolism in patients with nonvulvular atrial fibrillation, but Friday’s approval could greatly expand its reach to thousands more patients.

“As the number of hip and knee replacement surgeries performed in the U.S. continues to increase, the risk of DVT following these surgeries remains a concern for physicians,” said Steven Romano, head of Pfizer’s medicines development group.

“Eliquis provides patients and physicians with a new treatment option that offers twice daily oral dosing and no routine coagulation testing, and is broadly accessible through hospitals and managed health care formularies.”

According to BMS and Pfizer, around 719,000 total knee replacement surgeries and 332,000 hip replacement surgeries are performed in the U.S. Patients who undergo these surgeries are at increased risk for DVT, which can lead to pulmonary embolism and eventually death.

Eliquis was initially approved by the FDA in the last days of 2012. According to BMS’ annual report, the drug raked in $146 million in 2013. — Ferdous Al-Faruque

Subscribe to Drug Industry Daily for complete coverage of the pharmaceutical industry. Click here for more information.