Pfizer ($PFE) and Bristol-Myers Squibb ($BMY) have racked up more good news for their blood thinner Eliquis, a drug for which investors have outsized expectations if they can just get the FDA to approve for use in the U.S.
Last month, European regulators stamped their approval on Eliquis (apixaban) to prevent strokes in people with a heart-rhythm disorder known as atrial fibrillation. It was already approved there for prevention of blood clots in patients who undergo hip or knee replacement surgery. But the drugmakers have twice been turned away by the FDA for approval to use it to prevent stroke and systemic embolism in adult patients with NVAF. The agency has set a March 17, 2013, PDUFA date on the therapy.
Analysts expect that Eliquis can earn anywhere from $3 billion to more than $5 billion a year--provided it gets OK'd in the U.S. There are some 6 million people in Europe and another 6 million in the U.S. who suffer from atrial fibrillation. Add in a 25% chance of developing this condition after the age of 40, and the potential value of the treatment begins to become apparent. The regulatory delays have benefited some major-league competitors in the field that wrangled approvals earlier--Pradaxa and Xarelto--but analysts still see a big upside with the clear potential to dominate this critical drug market. Daiichi Sankyo also has a factor Xa inhibitor it hopes to get into the market next year, PMLive reports.
Results of a Phase III study show that patients could benefit from an extra year of treatment with the anticoagulant. The study, published in the New England Journal of Medicine, showed that Eliquis safely reduces long-term risk in patients suffering from venous thromboembolism, PMLive reports. Results were also presented at the American Society of Hematology meeting over the weekend. The companies said in a release that they have also received approval from Health Canada for Eliquis to prevent stroke and systemic embolism in patients with atrial fibrillation.
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