Bayer AG and GlaxoSmithKline plc announced that they have received a positive opinion from the European Committee for Proprietary Medicinal Products (CPMP) for Levitra (vardenafil), a new oral drug under regulatory assessment for the treatment of erectile dysfunction (ED). This means that a European Marketing Authorisation should be granted within the next few months followed by a launch in Europe in the first half of 2003.
Levitra was selected for development because of its in-vitro potency and high selectivity for the PDE-5 enzyme. Levitra was researched and developed by Bayer AG and will be co-promoted and co-developed with GlaxoSmithKline plc (GSK). As leading European-based companies, Bayer and GSK are poised to bring Levitra to market using their extensive network of local operating companies throughout the continent.
Dr. Wolfgang Plischke, PhD, president Bayer Pharmaceuticals division of Bayer Health Care, Bayer AG said, "This positive opinion from the CPMP -received earlier than anticipated - marks another important milestone, bringing us one step closer to the global launch of Levitra. The plans are in place to ensure an expedited launch at approval". "We are very pleased with the Committee's decision following their assessment of our extensive clinical trial data package that showed excellent efficacy following treatment with Levitra in men with ED", Robert A Ingram, Chief Operating Officer and President, Pharmaceutical Operations, GlaxoSmithKline.
The clinical data presented to the CPMP for Levitra included results from pivotal phase III studies of almost 4,000 men representing a broad patient population, including men of varying ages and severity of ED, and those considered challenging to treat, such as men with diabetes and those who have undergone prostatectomy. In one large-scale trial including a broad range of patients, 80 per cent of men taking Levitra 10 and 20mg respectively reported an improvement in erectile function compared with 28 per cent on placebo. In clinical trials, the most common adverse events reported for Levitra were headache, flushing, rhinitis and dyspepsia, events typical of PDE inhibition.
Erectile dysfunction (ED) - the inability to sustain an erection sufficient for sexual intercourse - is a major medical condition among men that is largely untreated. Although an estimated 152 million men are affected worldwide, research shows that only 10 per cent of men are being treated for the condition, suggesting the need for additional therapies in this area.