Almirall Launches Klisyri®?(Tirbanibulin) for the Treatment of Actinic Keratosis in Europe

-  The UK and Germany are the first two European countries where Klisyri^® will be available for prescription. The product has been approved for the treatment of actinic keratosis by the UK Medicines and Healthcare products Regulatory Agency (MHRA) and the European Commission

-  Klisyri^® (tirbanibulin) is a topical microtubule inhibitor indicated for the treatment of AK of the face or scalp in adults and it acts through a selective antiproliferative mechanism of action

-  This launch represents a significant step forward in the treatment of AK due to its efficacy, safety profile and convenient 5-day application period. Roll-out in Europe will continue in the following months

-  AK is one of the most common diagnoses made by dermatologists in Europe and its prevalence can be calculated to be around 18% of the population in Europe^[1],[2]

BARCELONA, Sept. 27, 2021 /PRNewswire/ -- Almirall S.A. (BME: ALM), a global biopharmaceutical company, announced today the commercial launch in Germany and the UK of Klisyri^® (tirbanibulin), approved by the European Commission and the UK Medicines & Healthcare products Regulatory Agency (MHRA) in July and August of 2021, respectively, for the topical treatment of actinic keratosis (AK) of the face and scalp in adults.

Klisyri^® (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 - one application daily for 5 days - proven efficacy and safety profile, with very acceptable local tolerability.

AK is a common skin condition caused by sun damage occurring mostly in zones that are chronically exposed to ultraviolet (UV) radiation. During the last years, its incidence has gone up due to an aging population, increased exposure to UV radiation, and changes in UV-seeking behaviors^[3] and is one of the most common diagnoses made by dermatologists in Europe. Its prevalence can be calculated to be around 18% of the population in this continent^[4],[2]. Data reported in the UK estimates a very similar prevalence, around 19-24% of the population over the age of 60 years ^[5]. In Germany, the estimated annual number of AK cases documented by dermatologists is about 1.7 million ^[6]. 

"The increase in the practice of outdoor activities and the excessive sun exposure without the correct protection have caused a rise in the number of cases of actinic keratoses diagnosed by dermatologists. It's important to identify and treat the lesions to help reduce the disease progression to skin cancer. In this context, the arrival of Klisyri^® to the market is an important addition to dermatologist's armamentarium" said Dr Girish Gupta, Consultant Dermatologist, Edinburgh, UK

The MHRA approved Klisyri^® following the approval of the European Commission in the EU in July 2021, and based on two pivotal phase III studies' (KX01-AK-003 and KX01-AK-004) positive results, published in the New England Journal of Medicine (NEJM)^[7]. These two, double-blind, vehicle-controlled, randomised, parallel-group, multi-centre phase III clinical trials included 702 patients from 62 clinical sites across the US, and demonstrated that once-daily application of tirbanibulin ointment 1% (10 mg/g) for 5 consecutive days in adults with AK on the face or scalp is effective and generally well tolerated.  Tirbanibulin met the primary endpoint, which was defined as 100% clearance of AK lesions at Day 57 within the face or scalp treatment areas, each study achieving a highly statistically significant result (p<0.0001).

"Almirall is privileged to bring a new, innovative medicine to potentially help millions of patients suffering from AK across Europe. Klisyri^® has been designed to demonstrate efficacy, whilst offering an advanced safety and tolerability profile that reduces severe local skin reactions. In addition, the convenient 5-day dosing regimen should significantly alleviate the burden conventional therapies put on patients," stated Gianfranco Nazzi, Almirall's Chief Executive Officer.

The commercialization of this product in the European continent marks another milestone achieved by Almirall in its mission to bring new and innovative solutions AK patients around the world an efficacious, generally well tolerated, and convenient treatment for this skin disease. In February 2021, Almirall started the commercialization of Klisyri^® in the USA and is currently  working on its roll-out in the rest of the European market. In addition, Almirall submitted Klisyri® for a marketing authorisation in Switzerland in December 2020 and the dossier is currently under review by Swissmedic.  

[1] Lucas R, McMichael T, Smith W, Armstrong B. Solar ultraviolet radiation: Global burden of disease from solar ultraviolet radiation: World Health Organization, 2006. 

[2] Worldometer. Population of Europe. 2020. Available at: https://www.worldometers.info/world-population/europe-population/ Accessed: October 2020. 

[3] Chetty P, Choi F, Mitchell T. Primary care review of actinic keratosis and its therapeutic options: a global perspective. Dermatol Ther (Heidelb) 2015; 5(1): 19-35

[4] Lucas R, McMichael T, Smith W, Armstrong B. Solar ultraviolet radiation: Global burden of disease from solar ultraviolet radiation: World Health Organization, 2006. 

[5] Guidelines for the management of actinic keratoses; British Association of Dermatologists (2007)

[6]  Schaefer I, Augustin M, Spehr C, Reusch M, Kornek T. Prevalence and risk factors of actinic keratoses in Germany--analysis of multisource data. Journal of the European Academy of Dermatology and Venereology : JEADV. 2014 Mar;28(3):309-313. DOI: 10.1111/jdv.12102. PMID: 23347271.

[7] 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.

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