Bayer HealthCare of Bayer AG and GlaxoSmithKline plc have received marketing authorisation from the European Commission for Levitra (vardenafil HCl), a new oral PDE-5 inhibitor for the treatment of male erectile dysfunction (ED). The decision follows a positive opinion by the European Committee for Proprietary Medicinal Products (CPMP) on 21 November 2002. Bayer and GSK anticipate launching Levitra as soon as possible in European markets. The drug has also been approved by regulatory authorities in several Latin American countries and has been submitted for approval to regulatory agencies in all major markets, including the United States.
"We are delighted with the European Commission's decision and look forward to bringing Levitra to market for the millions of men in Europe who could benefit from a new option to treat ED," said Dr. Christa Kreuzburg, Head of Europe for Bayer HealthCare's Pharmaceuticals Division. "We know that many men are not completely satisfied with existing treatments and are looking for effective new options. We believe Levitra will improve sexual satisfaction for men who have ED by providing them with a highly efficacious and reliable treatment. Together with GSK, we are committed to bringing this product to all European markets with initial launches starting this month," she added.
"Patients have responded extremely well to treatment with Levitra," said Ian Eardley, a Levitra clinical trial investigator and consultant at St. James University Hospital, Leeds, UK. "I view Levitra as an important first-line therapy in the broad population of men with ED -- even for difficult-to-treat patients, such as men with diabetes. I will prescribe it with confidence knowing that it will effectively treat a majority of my patients with impaired erectile function," he concluded.
The CPMP based its decision to recommend approval of Levitra on clinical data that included results from more than 3750 men representing a broad patient population. Levitra has been shown to work quickly and have reliable efficacy over time.
Erectile dysfunction is a common health condition, but despite the high prevalence of ED, the condition still goes largely untreated. Experts estimate that only 15-20 percent of the 152 million men worldwide are currently being treated.