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Pfizer, Bristol: FDA ruling on Eliquis postponed

By Linda A. Johnson
AP Business Writer / March 1, 2012
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TRENTON, N.J.—Federal regulators have pushed back the deadline for deciding whether to approve a highly touted 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.

The drugmakers, both based in New York, 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. All three could become blockbusters, bringing their makers much-needed new revenue.

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.

BernsteinResearch analyst Dr. Timothy Anderson wrote in a note to investors that he does expect such a review, in late May. He said a small delay won't hurt the companies much, "assuming there are no major issues with the product" and that the detailed package insert "reads favorably." He referred to analyst expectations that the FDA will allow companies to state that their drug has advantages over the two new drugs, as well as warfarin.

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.

Anderson noted he's been forecasting total Eliquis sales of $395 million this year, rising to $2.5 billion in 2015 and $3.7 billion by 2020.

"These numbers may need to be revised slightly," he wrote, because of the delay.

Bristol-Myers discovered Eliquis and since 2007 has been testing it in partnership with Pfizer, the world's largest drugmaker.

The drug was approved in May by the European Union for preventing blood clots in patients who have had hip or knee replacement surgery. However, the companies ultimately are aiming for a much bigger market, the millions of U.S. and European patients with atrial fibrillation, an irregular heartbeat that raises risk of life-threatening blood clots.

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.

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Linda A. Johnson can be followed at http://twitter.com/LindaJ--onPharma

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