EXTON, PA — Almirall, S.A. (BME: ALM), a global biopharmaceutical company focused on skin health, recently announced the U.S. commercial launch of Klisyri® (tirbanibulin), developed for the topical treatment of actinic keratosis (AK) of the face and scalp. Klisyri® was approved by the U.S. Food and Drug Administration (FDA) in December 2020 and is now commercially available.
Klisyri® is a novel, topical, first-in-class microtubule inhibitor that represents a significant step forward in the treatment of AK due to its short treatment protocol (once daily application for 5 days), and proven efficacy and safety profile. AK is the second most common diagnosis made by dermatologists in the United States.1 It is estimated that more than 40 million Americans develop actinic keratoses (AKs) each year.2
“Klisyri® will help address unmet needs for many AK patients,” said George Martin, MD, a world-renowned expert in actinic keratosis and skin cancer. “Early diagnosis and a safe and highly effective topical for treatment of actinic keratosis is critical. Patients with actinic keratoses are at higher risk for developing non-melanoma skin cancer. Actinic keratosis can progress into squamous cell carcinoma (SCC), a common and sometimes invasive and deadly form of skin cancer.”4
The FDA approved Klisyri® based on the data from one of the largest Phase III clinical study programs ever conducted for a topical AK treatment,3 consisting of two pivotal, randomized, double-blind, vehicle-controlled Phase III studies (KX01-AK-003 and KX01-AK-004) that evaluated the efficacy and safety of Klisyri® (tirbanibulin) ointment 1% in adults with AKs on the face or scalp.
Klisyri® met the primary endpoint and achieved a significantly higher number of patients with complete (100%) clearance of AK lesions at day 57 in the treated area compared to vehicle (44% vs. 5% in study 1 and 54% vs. 13% in study 2; p<0.0001 for both studies). It also met the secondary endpoint of partial (≥75%) clearance of lesions at day 57 compared to vehicle. The most common adverse events were application-site pruritus and pain seen in 9% and 10% of patients treated with Klisyri®.
Ayman Grada, MD, Head of R&D and Medical Affairs at Almirall U.S. added, “The incidence of actinic keratosis has been increasing,5,6 including in younger adults. Patients may prefer a treatment option with a short duration and proven safety and tolerability profile.7 The data for Klisyri offers this, as well as demonstrating efficacy for both face and scalp actinic keratoses.”4
“The U.S. launch of Klisyri marks another important milestone for Almirall toward our goal to be a leader in the field of dermatology and deliver new, innovative and effective treatment options,” said Pablo Alvarez, President and General Manager of Almirall U.S. “We are committed to providing patients with affordable access to our medications, and we have a copay card and a network of pharmacies covering the country to support this. We are excited to be able to offer this novel treatment option for dermatologists and their patients.”
IMPORTANT SAFETY INFORMATION
WARNINGS AND PRECAUTIONS
Ophthalmic Adverse Reactions
Almirall states KLISYRI may cause eye irritation. Avoid transfer of the drug into the eyes and to the periocular area during and after application. Wash hands immediately after application. If accidental exposure occurs, instruct patient to flush eyes with water and seek medical care as soon as possible.
Local Skin Reactions
Almirall states local skin reactions, including severe reactions (erythema, flaking/scaling, crusting, swelling, vesiculation/pustulation and erosion/ulceration) in the treated area can occur after topical application of KLISYRI. Avoid use until skin is healed from any previous drug, procedure, or surgical treatment. Occlusion after topical application of KLISYRI is more likely to result in irritation.
Almirall states the most common adverse reactions (incidence ≥2%) were local skin reactions, application site pruritus, and application site pain.
Please see Full Prescribing Information for Klisyri at www.klisyri.com.
- Wilmer EN, Gustafson CJ, Ahn CS, Davis SA, Feldman SR, Huang WW. Most common dermatologic conditions encountered by dermatologists and nondermatologists. Cutis. 2014 Dec;94(6):285-92
- Lim HW, MD, Collins SAB, et al. “The burden of skin disease in the United States.” J Am Acad Dermatol 2017;76:958-72
- Blauvelt A, Kempers S, Lain E, et al. Phase 3 Trials of Tirbanibulin Ointment for Actinic Keratosis. New England Journal of Medicine 2021;384:512-20
- Goldberg LH, Lebwohl M. Actinic keratosis overview [cited 2020 Nov 25]. Inn: The Skin Cancer Foundation [Internet]. New York (USA): The Skin Cancer Foundation; c2019
- Salasche SJ. Epidemiology of actinic keratoses and squamous cell carcinoma. J Am Acad Dermatol. 2000 Jan. 42(1 Pt 2):4-7. [Medline]
- Nestor MS, Zarraga MB. The incidence of nonmelanoma skin cancers and actinic keratoses in South Florida. The Journal of clinical and aesthetic dermatology. 2012 Apr;5(4):20.
- Steeb T, Wessely A, von Bubnoff D, et. al. Treatment Motivations and Expectations in Patients with Actinic Keratosis: A German-Wide Multicenter, Cross-Sectional Trial. Journal of Clinical Medicine. 2020; 9(5):1438
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