The FDA has granted Pfizer ($PFE) and Bristol-Myers Squibb ($BMY) priority review of the companies' anti-clotting drug Eliquis, promising a final ruling on the drug by March 28. The news comes a day after the U.K.'s cost effectiveness panel NICE gave the green light for Eliquis for preventing blood clots after hip and knee surgeries, just six months after the EMA approved the drug in Europe.
Pfizer and BMS' application is based on two large studies of Eliquis for the prevention of stroke and systemic embolism in patients with atrial fibrillation. Patients who received the new drug had better outcomes than those who got the standard treatment of warfarin. The two companies also reported that Eliquis cut the risk of stroke or systemic embolism 21%, major bleeding 31% and death 11%, as FierceBiotech noted in a recent report.
If approved, Eliquis will compete with Boehringer Ingelheim's Pradaxa and the Bayer/Johnson & Johnson drug Xarelto for a slice of the $9 billion anti-clotting market. Though Pfizer and BMS' drug will likely be the last to be approved, analysts think Eliquis' favorable efficacy and safety profile could make it a leader in the field. It would also offer a much-needed boost to Pfizer, which suffered the loss of patent protection for its best-selling drug Lipitor this year.
- here's Pfizer's release on the FDA news
- see The Wall Street Journal report
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