Research & Development
Almirall's Klisyri receives European Commission approval
20 July 2021 -

Almirall SA (BME: ALM), a Spain-based global biopharmaceutical company, announced on Monday that it has received approval from the European Commission for its Klisyri (tirbanibulin) intended for the topical treatment of actinic keratosis, a precancerous skin condition, on the face or scalp in adults.

The product is a novel, topical first-in-class microtubule inhibitor with a selective antiproliferative mechanism of action that is claimed to represent a significant step forward in the treatment of actinic keratosis due to its short treatment protocol, one application daily for five days, proven efficacy, and safety profile with very acceptable local tolerability.

The product received approval based on two pivotal phase III studies' (KX01-AK-003 and KX01-AK-004) positive results, published in the New England Journal of Medicine.

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