FDA expands approval for Klisyri to treat larger areas of actinic keratosis

The U.S. Food and Drug Administration has approved an expanded use of Klisyri (tirbanibulin) ointment to treat actinic keratosis (AK) on larger areas of the face or scalp, up to 100 cm², according to a press release. This single, 5-day topical regimen was originally approved in December 2020 for a treatment area of up to 25 cm².

Approval is based on a Phase 3, multicenter, open-label clinical safety study involving over 100 patients. The study evaluated the safety and tolerability of applying tirbanibulin to a 100 cm² area on the face or balding scalp, confirming consistency with the original trial results for smaller areas. Local skin reactions and treatment-related adverse events were similar to those observed in the initial trials.

Karl Ziegelbauer, Chief Scientific Officer at Almirall, said, “The FDA’s approval for a larger treatment area is a significant advancement, enabling more comprehensive care for patients with widespread AK, which can help prevent lesion progression.”

Read the full press release here.