OSAKA -- The European Commission has approved sale of a new drug developed by Takeda Chemical Industries Ltd. for treating erectile dysfunction.
The Japanese drugmaker said Tuesday that it plans to market the drug -- called Ixense -- in Germany, Austria, France and Italy.
Unlike the drug Viagra, which works through the bloodstream, Ixense works through the central nerves and has fewer side effects when taken with other drugs, such as high blood pressure medicine, according to a Takeda spokesman.
Takeda is preparing to apply again to get the drug approved in the United States. The company first applied to the U.S. Food and Drug Administration in June 1999, but withdrew its application a year later to wait for further data.
In getting the go ahead from the European Commission, the company provided additional results from clinical tests to establish the drug's safety. "As soon as steps for approval in the U.S. are taken, we will consider applying for approval from the Health Ministry in Japan," the spokesman said.
According to the company, around 36 million men in Europe and more than 100 million men worldwide suffer from erectile dysfunction.