Bayer/GSK Levitra EU approval
This article was originally published in Pharmaceutical Approvals Monthly
Executive Summary
Bayer/GlaxoSmithKline's erectile dysfunction therapy Levitra (vardenafil) receives marketing authorization in Europe, firms announce March 7. Approval of the PDE-5 inhibitor is based on clinical studies in 3,750 men. The Summary of Product Characteristics states that Levitra allows some men to attain an erection as early as 15 min. after dosing (25 min. for most men) and for up to nearly five hours after dosing, the firms say. The recommended starting dose of Levitra is 10 mg 25 to 60 min. before sexual activity. Vardenafil received a positive opinion from the European Committee for Proprietary Medicinal Products Nov. 21, 2002 (Pharmaceutical Approvals Monthly, Dec. 1, 2002, In Brief). Lilly ICOS' Cialis (tadalafil) beat Levitra to market with its Nov. 12, 2002 EU approval (see related story, p. 3). Tadalafil and vardenafil are both currently "approvable" at FDA, pending submission of additional short-term clinical pharmacology studies for each ED agen