Bayer and Johnson & Johnson’s campaign to widen the patient group for their heart drug Xarelto hit a snag when two smaller studies failed to show a statistically reliant benefit.
The blockbuster clot prevention drug could not be shown with statistical significance to help heart failure patients after an acute worsening of their condition, results from the so-called Commander HF trial showed on Monday.
The primary goal of showing a reduction in the risk of death, heart attack and stroke was not reached.
On Sunday, a separate study called Mariner produced no clear evidence that Xarelto reduced the rate of dangerous blood clots among a certain group of high-risk patients after discharge from hospital.
Bayer chalked up 3.3 billion euros ($3.84 billion) in Xarelto revenues last year, mainly from stroke prevention in the elderly, and expects annual sales to rise above 5 billion euros.
A Bayer spokesman said that the latest results, also presented at the European Society of Cardiology congress in Munich, did not change its peak sales estimate or have any implications for other conditions that Xarelto is approved for.
It is a reversal of fortunes for Bayer, which in July won approval for additional Xarelto use in the potentially lucrative market for atherosclerosis patients.
Bayer has the marketing rights for the drug outside the United States while partner J&J sells Xarelto in the U.S., with Bayer being eligible for royalties on U.S. sales of 20 to 30 percent. (Reuters)