December 15, 2020

The U.S. FDA has approved Klisyri® (tirbanibulin), manufactured by Almirall, to provide topical treatment of actinic keratosis (AK) on the face or scalp. Klisyri is a novel, first-in-class topical microtubule inhibitor.

Actinic keratosis lesions are rough, scaly patches that occur on the skin due to long-term ultraviolet radiation exposure from sources such as the sun and tanning beds. Patients who develop one AK lesion are likely to develop more. Because the lesions can be precancerous, they are often removed. Potential treatments include cryotherapy, chemical peels, photo or laser therapy, and topical creams and gels.

In clinical studies, up to 54% of patients treated with Klisyri achieved 100% clearance of AK lesions in the treated area compared to up to 13% of patients who received a version of the ointment that did not contain the active pharmaceutical ingredient. In addition, a significant portion of patients treated with Klisyri achieved at least 75% clearance of lesions in the treated area.

Recommended dosing is one single-use sachet applied to the affected area of the skin once daily for five days. Klisyri is supplied in boxes containing five sachets each.

Almirall plans to launch the product during the first quarter of 2021. Pricing is not yet available.

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