Healio: FDA expands Klisyri approval for actinic keratosis treatment on larger face, scalp areas FDA expands Klisyri approval for actinic keratosis treatment on larger face, scalp areas Tirbanibulin ointment 1% shows good safety and tolerability in the treatment of actinic keratosis (AK) in fields of up to 100 cm 2 on the face and scalp. The most common local effects of treatment ... The US Food and Drug Administration has approved a supplemental new drug application for tirbanibulin topical ointment, allowing the expansion of the surface area treated for actinic keratosis (AK) of ...

Understanding the Context

Over 58 million Americans have actinic keratosis, a skin condition caused by damage from the sunโ€™s ultraviolet (UV) rays. With this condition, you develop scaly, discolored spots called actinic ... Monthly Prescribing Reference: Klisyri Approved to Treat Actinic Keratosis Over Larger Surface Areas Credit: Almirall. The expanded approval was based on data from a phase 3 safety study which evaluated tirbanibulin in more than 100 adult patients with actinic keratosis.

Key Insights

Findings showed the safety ... Pharmacology: The mechanism of action by which ingenol mebutate induces cell death in treating actinic keratosis lesions is unknown. Clinical trials: In two double-blind, vehicle-controlled, clinical ...