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Almirall’s Klisyri receives expanded FDA approval to treat actinic keratosis
临床结果临床3期上市批准引进/卖出
Almirall has announced that Klisyri (tirbanibulin) has received expanded approval from the US Food and Drug Administration (FDA) to treat actinic keratosis (AK), a common precancerous condition.
Almiralloval follows the company’s supplemental new drug application (sNDA) to expand the use Food and Drug Administration (FDA)ent on areactinic keratosis (AK)p to up to 100 cm2.
Characterised by rough, scaly patches of skin, AK is estimated to be responsible for 60% of all squammicrotubule inhibitormicrotubulercinoma cases, the second most common form of skin cancer.
According to a recent survey by Almirall as part of AK Global Day 2024, AK has an estimated prevsquamous cell carcinomape and 50% of the population experienceskin cancert least once a year.
Results for the safetyFDAd tolerability of Klisyri conducted on an area of 100 cm2 on the face or balding scalp of patients was consistent with the original pivotal trials conducted on an area of 25 cm2 for both local skin reactions and treatment-related adverse events, while also showing a percent reduction in AK lesion count in line with the one reported in the original studies.
Commenting on the approval, Karl ZiegelbaueKlisyrif scientific officer, Almirall, said: “The FDA’s approval of the use of Klisyri for AK on an extended surface of the face or scalp is a significant step forward for both patients and treating dermatologists.
Klisyri has already received several approvals, including from the EU and UK in 2021, as a one-application daily treatment for five days for AK of the face and scalp in adults.
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