Saturday, June 15, 2024

Expanded FDA Approval for Actinic Keratosis Treatment Almirall’s Klisyri®

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Actinic keratosis (AK) treatment on larger areas of the face or scalp, up to 100 cm2, the recent U.S. Food and Drug Administration (FDA) approval expands the use of Almirall’s Klisyri. This extension aims to address more extensive manifestations of AK, offering convenience for both patients and dermatologists. Safety and tolerability profiles in Klisyri treatment of AK in the expanded area are consistent with the original pivotal trial results.

Actinic keratosis is the most common pre-cancerous dermatological condition, and the second most common diagnosis made by dermatologists in the United States, with a reported prevalence of between 11% and 25%. The approval of Klisyri for an expanded treatment area represents a significant advancement in the management of AK, particularly for patients with more extensive lesions.

Expanding Treatment Flexibility: New Approval for Actinic Keratosis Treatment

The new approval allows clinicians to treat up to four times the surface area, providing increased flexibility in treatment approaches. This approval was supported by an additional Phase 3 clinical safety study involving over 100 patients in the US. The study evaluated the safety and tolerability of applying tirbanibulin to a field of approximately 100 cm2 on the face or balding scalp of adult AK patients, showing consistent results with the original pivotal trials.

Furthermore, the effectiveness of tirbanibulin in a larger treatment area was explored, demonstrating a reduction in AK lesion count comparable to that reported in the original pivotal studies. This expanded approval will enable clinicians to treat a larger area of the face or balding scalp, offering more patients access to effective AK treatment.

Actinic Keratosis

Klisyri’s Expanded Package Sizes for Actinic Keratosis Management

Klisyri will now be available in two package sizes, 250 mg for the treatment of up to 25 cm2, and 350 mg for up to 100 cm2, providing options for different treatment scenarios. It’s important for clinicians and patients to consider the safety information provided, including warnings and precautions regarding ophthalmic adverse reactions and local skin reactions.

In conclusion, the FDA’s approval of Klisyri for an expanded treatment area represents a significant advancement in the management of actinic keratosis. This approval will provide dermatologists with increased flexibility in treatment options and offer more patients access to effective treatment for AK, ultimately contributing to improved patient outcomes and quality of life.


Resource: Businesswire, June 10, 2024

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