Approval allows Almirall to move forward with the topical ointment for individuals with AK on the face or scalp.
The US Food and Drug Administration (FDA) has approved tirbanibulin (Klisyri) as a topical treatment for actinic keratosis (AK).
The approval, awarded to Almirall, S.A., will allow the novel, topical first-in-class microtubule inhibitor for treatment of the disease on the face or scalp, representing a significant breakthrough in treatment of AK because of its short treatment protocol of once daily application for 5 days.
Actinic keratosis represents the second most common diagnosis in dermatology in the US, with a reported prevalence between 11-25%.
"Early diagnosis and treatment of actinic keratosis (AK) is critical, since those who already have an AK are likely to develop more actinic keratoses (plural) in the future," said Deborah S. Sarnoff, MD, President of the Skin Cancer Foundation, said in a statement. "Patients with AK are at higher risk for skin cancer, since AKs can progress into squamous cell carcinoma (SCC), a common and sometimes invasive form of skin cancer."
The approval is based on recent data from a large phase 3 clinical study, as well as 2 randomized, double-blind, vehicle-controlled phase 3 studies evaluating the efficacy and safety of tirbanibulin ointment 1% in adults with AK on the face or scalp.
"These studies enrolled a total of 702 patients across 62 sites in the United States, providing robust data,” Andrew Blauvelt, MD, MBA, President of Oregon Medical Research Center, and one of the lead investigators of the studies, said in a statement. “Tirbanibulin achieved a significantly higher number of patients with complete (100%) clearance of AK lesions in the treated area compared to vehicle (44% vs. 5% in study 1 and 54% vs. 13% in study 2), as well as reaching the secondary endpoint of partial (≥75%) clearance of lesions.”