Zyclara imiquimod regulatory update

The European Commission approved an MAA for Zyclara imiquimod 3.75% from Meda to treat actinic keratosis (AK) on large skin areas. Meda said it plans to launch the product in Europe early next year. The immune response modifier is approved in the U.S. to treat AK and in the U.S. and Canada to treat external genital warts and perianal warts. A 2.5% formulation is also approved in the U.S. to treat clinically typical, visible or palpable AK (see BioCentury, July 25, 2011). Meda and Graceway Pharmaceuticals LLC market a 5% formulation of the product as Aldara in Europe and the U.S., respectively, to treat AK, external genital and perianal warts and small superficial basal cell carcinoma (BCC). ...