CHMP recommends EU approval of Zyclara (Meda) for Actinic Keratoses

The CHMP has adopted a positive opinion regarding marketing authorization of Zyclara (imiquimod), from Meda, for the treatment of Actinic Keratoses (AK) on large skin areas. Zyclara shares the same active ingredient as Aldara and while both are approved by the FDA for the treatment of AK, there are key differences: Zyclara is indicated for daily use on an accelerated 6-week dosing cycle, while Aldara is not approved for daily use and its dosing regimen is for a full 16 weeks. Zyclara is also indicated for use on larger areas of skin, the full face or balding scalp, while Aldara is restricted to a smaller area of skin.