Levitra receives positive opinion from CPMP

Published: 1-Jan-2003
Regulatory


Bayer and GlaxoSmithKline 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 clears the way for a launch in Europe in the first half of 2003, once a European Marketing Authorisation is granted, probably within the next few months.

Dr Wolfgang Plischke, president, Bayer Pharmaceuticals division of Bayer Health Care, 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. Plans are in place to ensure an expedited launch at approval.' Vardenafil was selected for clinical development because of its in vitro potency and high selectivity for the PDE-5 enzyme. In one large-scale trial 80% and 85% of men taking Levitra 10 and 20mg respectively reported an improvement in erectile function compared with 28% on placebo. Although an estimated 152m men worldwide are affected by ED, only 10% are being treated for the condition, suggesting the need for additional therapies.

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