Europe's CHMP backs Sanofi Pasteur's Humenza and GSK's Votrient; gives opinions on other products

The European Medicines Agency (EMEA) Committee for Medicinal Products for Human Use (CHMP) announced a number of decisions resulting from its February 15-19 meetings, including recommending the granting of a conditional marketing authorization for a fifth pandemic vaccine, Humenza (split virion, inactivated, AF03 adjuvanted influenza H1N1 pandemic vaccine), from Sanofi Pasteur, a unit of French drug major Sanofi-Aventis, intended for the prophylaxis of influenza in an officially declared pandemic situation. This recommendation was made using an emergency procedure which fast-tracks evaluation of new vaccines developed during a pandemic.

The Committee also adopted a positive opinion, recommending the granting of a conditional marketing authorization, for Votrient (pazopanib), from UK drugs giant GlaxoSmithKline, intended for the treatment of patients with advanced renal cell carcinoma. The review the drug began on March 25, 2009, with an active review time of 210 days. Votrient is the 63rd orphan medicinal product to receive a positive opinion by the CHMP.

Positive opinion for generic Taxotere and Zanamivir