Athenex Announces Phased European Launch of Klisyri® (tirbanibulin) for the Treatment of Actinic Keratosis
Klisyri has been approved for the treatment of actinic keratosis by the
AK is one of the most common diagnoses made by dermatologists in
Tirbanibulin is a novel, topical first-in-class microtubule inhibitor with a selective antiproliferative mechanism of action that we believe 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.
“We are extremely pleased to see Klisyri launching in these two major European markets by our partner Almirall,” said Dr.
Under the terms of the license agreement with Almirall,
About Klisyri® (tirbanibulin)
Klisyri® (tirbanibulin) is a microtubule inhibitor indicated for the topical treatment of actinic keratosis (AK) 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 AK 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 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.
About Athenex, Inc.
Founded in 2003, Athenex, Inc. is a global clinical stage biopharmaceutical company dedicated to becoming a leader in the discovery, development, and commercialization of next generation drugs for the treatment of cancer. Athenex is organized around three platforms, including an Oncology Innovation Platform, a Commercial Platform, and a Global Supply Chain Platform. The Company’s current clinical pipeline is derived from four different technologies: (1) Orascovery, based on P-glycoprotein inhibitor, (2) Src kinase inhibition, (3) Cell therapy, and (4) Arginine deprivation therapy. Athenex’s employees worldwide are dedicated to improving the lives of cancer patients by creating more active and tolerable treatments. For more information, please visit www.athenex.com.
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- Blauvelt A, Kempers S, Lain E, et al. Phase 3 Trials of Tirbanibulin Ointment for Actinic Keratosis.
New England Journal of Medicine. 2021 Feb 11;384(6):512-520. 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: Athenex, Inc.