FDA approves Graceway Pharmaceuticals' NDA for Zyclara

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."    

In clinical trials, with patients averaging 11 AKs at baseline, Zyclara reduced the total number of AKs by 82 percent.  Complete clearance of all AKs (including lesions revealed during treatment) was achieved in 36 percent of patients as compared to only 6 percent of those on placebo.  Partial clearance (75 percent reduction or greater in AK totals) was achieved in 59 percent of those treated with Zyclara versus 23 percent for placebo.  Additionally, over 85 percent of patients experienced an increase in AK counts after the start of Zyclara treatment.  Clearance rates reflect treatment of visible lesions at baseline, as well as new lesions revealed during treatment.

"Because AKs are pre-cancerous and can develop on skin frequently exposed to the sun, such as the face or balding scalp, an effective treatment that can be used on large areas of skin is beneficial," said Darrell Rigel, M.D., clinical professor of dermatology, New York University Medical Center.  "The approval of Zyclara may offer patients a convenient option for treating multiple AKs in a single short course of treatment."

Zyclara will be supplied in a new 28-sachet pack comprised of single-use packets, each of which contains 250 mg of cream.  Because the dose is controlled, it may make the 6-week dosing regimen more intuitive for patients.