FDA expands approval for Almirall’s Klisyri

The US Food and Drug Administration (FDA) has approved the recent supplemental New Drug Application (sNDA), submitted by Spanish dermatology focused drugmaker Almirall (ALM: MC), to expand the use area for its drug Klisyri (tirbanibulin) to up to 100 cm.

Klisyri, a microtubule inhibitor ointment, is now approved in a 350mg package size and is a five-day topical field treatment for actinic keratosis (AK) of the face or scalp. Klisyri was first approved by the FDA in December 2020 to treat actinic keratosis of the face or scalp.

“The FDA’s approval of the use of Klisyri for actinic keratosis on an extended surface of the face or scalp is a significant step forward for both patients and treating dermatologists. 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,” said Almirall’s chief scientific officer Karl Ziegelbauer.