FDA approves tirbanibulin (Klisyri) ointment for the treatment of actinic keratosis on the face or scalp

Approval of this microtubule inhibitor was based on data from two randomised, double-blind, vehicle-controlled phase III studies (KX01-AK-003 and KX01-AK-004) in 702 adults which showed complete clearance of lesions at day 57 in significantly higher number of patients vs. vehicle

SPS commentary:

In the KX01-AK-003 study, complete clearance was observed in 44% of patients treated with tirbanibulin vs. 5% for the vehicle treated groups and in the KX01-AK-004 study, figures were 54% vs. 13% (both p<0.0001). 

In March 2020, tirbanibulin was filed for approval in the EU for treatment of actinic keratosis.

Biospace Inc.