FRANKFURT (Reuters) - Europe’s drug regulator said on Friday the defective blood clotting test device used in a key trial for the approval of Bayer’s top-selling anti-clotting drug Xarelto did not distort the study’s main findings.
“Xarelto can continue to be used as before, in line with the current prescribing information,” the European Medicines Agency (EMA) said on its website.
The study known as ROCKET compared Xarelto with older drug warfarin for preventing strokes in patients with a type of irregular heartbeat common among the elderly.
That is by far the biggest market for the drug, which Bayer jointly developed with Johnson & Johnson, and which competes with Bristol Myers-Squibb and Pfizer’s Eliquis.
A so-called INR device by Alere, which measures how quickly blood starts clotting and which was used in the trial, was recalled in December 2014 after giving falsely low test results.
“A defect with the international normalized ratio (INR) device used in the ROCKET study does not change its conclusions on the overall safety or benefit-risk balance of Xarelto,” EMA said in the statement. Bayer said at the end of October that Xarelto has a 34 percent market share globally. Bayer chalked up 1.68 billion euros ($1.8 billion) in revenue from Xarelto in 2014 and 1.60 billion in the first nine months of 2015, up 38 percent from a year earlier, making it Bayer’s best-selling drug.
Reporting by Ludwig Burger; Editing by Maria Sheahan