Germany’s Bayer unveils European approval for gynaecological drug
Bayer said the drug would go on sale in Europe in 2010 and will provide relief from pain associated with lesions and inflammation outside the uterus.Frankfurt -- The German pharmaceutical and chemical group Bayer said last week it had won European approval for its Visanne drug, which treats the gynaecological disease endometriosis.
In the United States meanwhile, Bayer is still waiting for a green light for Rivaroxaban, a blood thinning treatment.
Bayer said Visanne would go on sale in Europe in the second quarter of 2010, and will provide relief from pain associated with lesions and inflammation outside the uterus.
The company said the condition affects around five to 10 percent of women of childbearing age.
"Lower abdominal and pelvic pain, cramping menstrual pains (dysmenorrhea), painful sexual intercourse (dyspareunia) and infertility are well recognized symptoms of endometriosis," a statement said.
Last week however, Bayer said regulatory approval of Rivaroxaban in the United States had not been completed, and that the company would not be able to provide the US Food and Drug Administration (FDA) with additional information as requested, by the end of the year.
Rivaroxaban has been used in tests to treat thrombosis or blood clots following hip and knee operations.
Bayer originally sought FDA approval for the drug in July 2008, but US authorities have requested more information on it.
Sold under the dame Xarelto in Europe, the drug is one of Bayer's best hopes for its health-care division, along with the cancer treatment Nexavar.
Shares in Bayer lost 2.01 percent to 52.65 euros in early Frankfurt trading on the news, while the DAX index of leading German stocks was 0.97 percent lower overall.