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news.Graceway Pharmaceuticals has received FDA approval for the new drug application (NDA) of Zyclara, for the treatment of clinically typical, visible or palpable actinic keratoses (AK).
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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.
Graceway Pharma said that 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.
However, 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 25cm2 area of skin.
In clinical trials, with patients averaging 11 AKs at baseline, Zyclara reduced the total number of AKs by 82%. Complete clearance of all AKs (including lesions revealed during treatment) was achieved in 36% of patients as compared to only 6% of those on placebo.
In the trial, partial clearance (75% reduction or greater in AK totals) was achieved in 59% of those treated with Zyclara versus 23% for placebo. Additionally, over 85% 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.
Zyclara will be supplied in a new 28-sachet pack comprised of single-use packets, each of which contains 250mg of cream. Because the dose is controlled, it may make the 6-week dosing regimen more intuitive for patients, said the company.
Jefferson Gregory, chairman and CEO of Graceway Pharma, said: “When Graceway acquired Aldara, we knew we had a good product for treating actinic keratoses, but we believed we could improve it. In Zyclara clinical trials, we successfully defined a shorter treatment regimen for a larger surface area with an excellent efficacy and safety profile.”