FDA expands Klisyri approval for actinic keratosis treatment on larger face, scalp areas
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Key takeaways:
- The FDA expanded Klisyri’s approved treatment surface area from 25 cm2 to up to 100 cm2.
- This approval was supported by additional phase 3 safety data.
The FDA has approved the expanded use area of Klisyri to up to 100 cm2 on the face and scalp for the treatment of actinic keratosis, Almirall announced in a press release.
Klisyri (tirbanibulin) 1%, a microtubule inhibitor ointment, was originally approved in December 2020 for the treatment of extensive actinic keratosis (AK) manifestations up to 25 cm2 on the face and scalp. The expanded approval now allows the drug’s utility up to 100 cm2 on these affected areas.
“The FDA’s approval of the use of Klisyri for AK on an extended surface of the face or scalp is a significant step forward for both patients and treating dermatologists,” Karl Ziegelbauer, chief scientific officer at Almirall, said in the release. “With patients experiencing AK over larger surface areas, dermatologists are looking for ways to treat the entire affected area to help prevent further lesion progression.”
The approval of Almirall’s supplemental new drug application was supported by phase 3, multicenter, open-label, clinical safety results which showed that Klisyri is just as safe on a larger surface area as it is on a smaller surface area with no increase of adverse events being observed.
Klisyri will now be available in the originally approved 250 mg package for the treatment of up to 25 cm2 as well as the new 350 mg package for up to 100 cm2 of the face and scalp.
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