- Klisyri® (tirbanibulin) is a novel microtubule inhibitor, indicated for the topical treatment of actinic keratosis (AK) and it acts through a selective antiproliferative mechanism of action
- The positive opinion is based on the results from two pivotal phase III clinical trials which demonstrated complete clearance of AK lesions at day 57 in treated face or scalp areas in a significantly higher number of patients than with vehicle, together with a very acceptable tolerability profile
- With the positive opinion of the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA), tirbanibulin edges closer to European Commission approval, expected in approximately 60 days
- The regulatory approval of Klisyri® (tirbanibulin) from the EMA would represent a significant step forward in the treatment of AK due to its short treatment protocol -once daily application for 5 days-, proven efficacy and safety profile
BARCELONA, Spain, May 21, 2021 /PRNewswire/ -- Almirall S.A. (BME: ALM), a global biopharmaceutical company, announced today that the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) has issued a positive opinion for the regulatory approval of Klisyri® (tirbanibulin), indicated for the topical treatment of actinic keratosis (AK) on the face or scalp.
Tirbanibulin is a novel, topical first-in-class microtubule inhibitor with a selective antiproliferative mechanism of action that represents a significant step forward in the treatment of AK due to its short treatment protocol - once daily application for 5 days -, proven efficacy and safety profile with very acceptable local tolerability.
AK is one of the most common diagnoses in dermatology practices and data available suggests that its prevalence can be calculated to be around 18% of the population in Europe,. Treatment is a critical aspect of the disease as it may progress to invasive squamous cell carcinoma (SCC).
In December 2020, Almirall's development partner, Athenex, Inc., received approval from the U.S. Food and Drug Administration (FDA) for the commercialisation of Klisyri® (tirbanibulin) in the United States for the topical treatment of actinic AK of 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. To this end early feedback from dermatologists in the US, has been very encouraging. The short duration of treatment, combined with proven efficacy and a good safety and tolerability profile should result in improved adherence to therapy, making Klisyri® a valid alternative to current treatment options for AK in the EU", stated Volker Koscielny, Chief Medical Officer at Almirall.
The CHMP opinion is based on two phase III studies (KX01-AK-003 and KX01-AK-004) positive results. These two double-blind, vehicle-controlled, randomized, parallel-group, multi-centre phase III clinical trials, which included 702 patients from 62 clinical sites across the US, showed that application of tirbanibulin ointment 1% (10 mg/g) in adults with AK on the face or scalp is effective and well tolerated.
Both phase III studies achieved their primary endpoint, which was defined as 100% clearance of the AK lesions at Day 57 within the face or scalp treatment areas, each study achieving statistical significance (p<0.0001) on this endpoint. In the KX01-AK-003 study, complete clearance was observed in 44% of the patients treated with tirbanibulin versus 5% for vehicle-treated groups. In the KX01-AK-004 study, complete clearance was observed in 54% of the patients treated with tirbanibulin versus 13% for vehicle-treated groups. Local reactions were mostly mild-to-moderate erythema, flaking or scaling, application-site pruritus, and application-site pain that resolved spontaneously.
The European Commission (EC) generally follows the recommendations of the CHMP (EMA) and delivers its final decision thereafter. The approval of Klisyri® (tirbanibulin) is expected in approximately 60 days and its launch in Europe could take place in late 2021. Concerning other territories, Almirall submitted for a marketing authorisation in Switzerland in Q4 2020 and the dossier is currently under review by Swissmedic. The company will also submit in Great Britain via the European Commission Decision Reliance Procedure.
About Klisyri® (tirbanibulin)
Klisyri® (tirbanibulin) is a microtubule inhibitor indicated for the topical treatment of actinic keratosis of the face or scalp. Two phase III studies (KX01-AK-003 and KX01-AK-004) evaluated the efficacy and safety of tirbanibulin ointment 1% (10 mg/g) in adults with actinic keratosis on the face or scalp. The studies achieved their primary endpoint, which was defined as 100% clearance of the AK lesions at Day 57 within the face or scalp treatment areas, each study achieving statistical significance (p<0.0001) on this endpoint.
About Actinic Keratosis
Actinic keratosis (AK) or solar keratosis is a chronic and precancerous skin disease that occurs primarily in areas that have been exposed to ultraviolet (UV) radiation for a long period of time. It is usually found on the face, ears, lips, bald scalp, forearms, the posterior part of the hands, and lower legs. It is not possible to predict which AK lesions will develop into squamous cell carcinoma. AK is the most common pre-cancerous dermatological condition.
Almirall is a global biopharmaceutical company focused on skin health. We collaborate with scientists and healthcare professionals to address patient's needs through science to improve their lives. Our Noble Purpose is at the core of our work: "Transform the patients' world by helping them realize their hopes and dreams for a healthy life". We invest in differentiated and ground-breaking medical dermatology products to bring our innovative solutions to patients in need.
The company, founded in 1943 and headquartered in Barcelona, is publicly traded on the Spanish Stock Exchange and is a member of the IBEX35 (ticker: ALM). Throughout its 77-year history, Almirall has retained a strong focus on the needs of patients. Currently, Almirall has a direct presence in 21 countries and strategic agreements in over 70, through 13 subsidiaries, with about 1,800 employees. Total revenues in 2020 were 814.5 million euros.
For more information, please visit almirall.com
 Lucas R, McMichael T, Smith W, Armstrong B. Solar ultraviolet radiation: Global burden of disease from solar ultraviolet radiation: World Health Organization, 2006.
 Worldometer. Population of Europe. 2020. Available at: https://www.worldometers.info/world-population/europe-population/ Accessed: October 2020.
 Blauvelt A, Kempers S, Lain E, et al. Phase 3 Trials of Tirbanibulin Ointment for Actinic Keratosis. N Engl J Med. 2021 Feb 11;384(6):512-520. doi: 10.1056/NEJMoa2024040
 Skin Cancer Foundation. Actinic Keratosis Overview. Available at: https://www.skincancer.org/skin-cancer-information/actinic-keratosis/#:~:text=Actinic%20keratosis%20(AK)%20is%20the,to%20ultraviolet%20(UV)%20radiation January 2021
SOURCE Almirall, S.A.