CHMP issues positive opinion of Klisyri for actinic keratosis

Klisyri has received a positive opinion for the treatment of actinic keratosis from the European Medicines Agency’s Committee for Medicinal Products for Human Use, Almirall announced in a press release.

A novel topical microtubule inhibitor, Klisyri (tirbanibulin) is applied once daily for 5 days to treat actinic keratosis (AK) on the face or scalp.

“We are delighted to receive the positive recommendation announced by the CHMP for Klisyri. The medicine represents an important therapeutic option for dermatologists and their patients in Europe,” Volker Koscielny, chief medical officer at Almirall, said in the release. “To this end, early feedback from dermatologists in the U.S. has been very encouraging. The short duration of treatment, combined with proven efficacy and a good safety and tolerability profile, may result in improved adherence to therapy, making Klisyri a valid alternative to current treatment options for AK in the EU.”

The opinion is based on results of two phase 3 clinical trials that found tirbanibulin ointment 1% improved AK lesions in a statistically significant number of patients compared with vehicle at day 57. In the KX01-AK-003 trial, 44% of patients reach 100% AK lesion clearance compared with 5% of vehicle-treated patients. In the KX01-AK-004 trial, 54% of the tirbanibulin group had 100% clearance compared with 13% of the vehicle group.

The drug was approved by the FDA in December 2020, and European approval is expected later this year.