Anti-Clotting Drug May Be Approved in EU
Advisers to European Union regulators have recommended approval of a new anti-clotting drug for use by adults with a common irregular heart rhythm that boosts risk of strokes or blood clots, drugmakers Bristol-Myers Squibb Co. and Pfizer Inc. said.
The drug, Eliquis, is a crucial one for the two companies, which have been slammed by new generic competition slashing sales of their top-selling drugs. Meanwhile, the partners are trailing competitors in a three-way race for global market share in a new class of anti-clotting drugs expected to be blockbusters, with sales well over $1 billion a year.
Pfizer and Bristol-Myers, both based in New York, said Friday advisers to the European Medicines Agency have issued a positive opinion on Eliquis for use in patients with the irregular rhythm called atrial fibrillation if it's not caused by a heart valve problem. If the European Medicines Agency approves it, that would allow sales in all 27 European Union member states, as well as Iceland and Norway.
The drug got its first approval in May 2011, also in the EU, for treating a much smaller group of patients, adults who have had hip or knee replacement surgery.
However, the U.S. Food and Drug Administration has rejected the drug twice, most recently in June. The agency said it needed more information on "data management and verification" from a huge international study called ARISTOTLE, but the FDA did not require new studies. That would have delayed any potential approval for a couple of years.