FDA takes more time to decide on the fate of BMS & Pfizer’s joint venture anticlotting drug Eliquis

By Dr. Ananya Mandal, MDMar 2 2012

The U.S FDA have pushed back the deadline for deciding whether to approve an experimental anticlotting drug developed jointly by Pfizer Inc. and Bristol-Myers Squibb Co. The companies said late Wednesday that the Food and Drug Administration has set a new target date of June 28 for deciding whether to approve Eliquis. That’s three months later than originally scheduled.

Both companies are based in New York and they said that after submitting their original application for approval of the drug, they sent the FDA additional information from patient studies. The new information will require more time for review.

Eliquis, known chemically as apixaban, is one of three new drugs meant to prevent heart attacks and strokes better than the longtime standard treatment, warfarin. The other two are already approved in the U.S. Doctors and patients have long wanted a better alternative to warfarin, an inexpensive generic drug also sold under brand names such as Coumadin. That’s because getting the dose of warfarin correct is so tricky that patients must have frequent blood tests to ensure they’re getting enough to prevent clots but not enough to cause internal bleeding.

Pfizer and Bristol-Myers said in a statement that they will continue to work closely with the FDA on the review. “At this stage there are no plans for an FDA advisory committee meeting to review the (application) for Eliquis,” they said.

Bristol-Myers discovered Eliquis and since 2007 has been testing it in partnership with Pfizer, the world’s largest drugmaker. In May 2011, Bristol-Myers Squibb and Pfizer announced the first regulatory approval for Eliquis in the 27 countries of the European Union (EU) for the prevention of venous thromboembolic events (VTE) in adult patients who have undergone elective hip or knee replacement surgery.

Eliquis is being investigated within the EXPANSE Clinical Trials Program, which is projected to include nearly 60,000 patients worldwide across multiple indications and patient populations and includes a total of nine completed or ongoing, randomized, double-blind Phase 3 trials.

The first of the new anticlotting drugs, Boehringer Ingelheim GmbH’s Pradaxa, also known as dabigatran, was approved in October 2010 for patients with atrial fibrillation. Meanwhile, Johnson & Johnson is awaiting U.S. approval for a third use for its anticlotting pill, Xarelto, for patients with acute coronary syndrome — narrowed or blocked blood vessels that can trigger dangerous chest pain or a heart attack. Xarelto, or rivaroxaban, is approved for patients with atrial fibrillation and for preventing blood clots after hip or knee replacement surgery.