Graceway® Pharmaceuticals announced today that the Food and Drug Administration (FDA) has approved the New Drug Application (NDA) for Zyclara™, determining it to be safe and effective for the treatment of clinically typical, visible or palpable actinic keratoses (AK). The new treatment can be used on large areas of skin, including the full face or balding scalp on a convenient, 6-week dosing cycle.
Zyclara shares the same active ingredient as Aldara® (imiquimod) Cream, 5% and while both topicals are FDA-approved for the treatment of AK, there are notable differences between the two. Zyclara is indicated for daily use on an accelerated 6-week dosing cycle comprised of two weeks of daily treatment with Zyclara, two weeks of non-treatment, followed by two weeks of daily treatment with Zyclara. Aldara is not approved for daily use and its approved dosing regimen is for a full 16 weeks. Additionally, Zyclara is indicated for use on larger areas of skin, the full face or balding scalp, while Aldara is restricted to a 25 cm2 area of skin.
If there are AKs visible on the surface of the skin, it is likely that there are more AKs just below the skin's surface. Zyclara revealed these AKs, in 86 percent of patients. In the study, Zyclara treated both types of AKs – those found at the start of the study and those unmasked during treatment. Additionally, over 40 percent of doctors reported Zyclara "significantly improved" the appearance of patients' skin.
"When Graceway acquired Aldara, we knew we had a good product for treating actinic keratoses, but we believed we could improve it," said Jefferson J. Gregory, chairman and CEO of Graceway Pharmaceuticals. "In Zyclara clinical trials, we successfully defined a shorter treatment regimen for a larger surface area with an excellent efficacy and safety profile."