German regulator sees no new risks from Bayer's Xarelto
FRANKFURT, Sept 9
FRANKFURT, Sept 9 (Reuters) - The number of reported side effects linked to Bayer's stroke prevention pill Xarelto is below worrisome levels, a German drugs regulator said, responding to a media report highlighting risks from taking the blood thinning drug.
"There is no new risk situation," a spokesman for Germany's Federal Institute for Drugs and Medical Devices (BfArM) said on Monday.
German magazine Der Spiegel reported over the weekend that Bayer faced a growing number of reports of bleeding in patients taking Xarelto, citing BfArM figures.
Bayer shares had declined 1.7 percent by 1208 GMT, while Germany's blue-chip index DAX was little changed.
"Xarelto is a major drug hopeful for Bayer and it's not good if a shadow is cast over it," said NordLB-analyst Thorsten Strauss.
Bayer won regulatory approval in Europe for the drug's main use, preventing strokes in patients suffering from a common form of irregular heart beat, in December 2011.
There were 968 cases of suspected undesirable side-effects related to Xarelto in the first eight months of 2013, including 72 deaths, the magazine reported.
BfArM said that, while the figures were within a range that was to be expected, the regulator would continue to monitor reported side effects.
A spokesman for Bayer said Xarelto's risk-benefit profile was still intact.
Jointly developed with U.S. peer Johnson & Johnson, Xarelto is one of Bayer's most important new drugs, expected to yield annual peak sales of more than 2 billion euros ($2.63 billion).
The stroke preventer, which is also used to treat and prevent deep vein thrombosis and pulmonary embolisms, competes with Eliquis, sold by Pfizer and Bristol-Myers Squibb , and with Boehringer Ingelheim's Pradaxa.