New FDA Approvals: FDA Expanded Almirall’s Klisyri Treatment Area
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Jul 11, 2024
June 7: The FDA expanded the treatment area of Almirall, LLC’s Klisyri (tirbanibulin) from up to 25 cm2 of the face or scalp to up to 100 cm2 for the treatment of adults with actinic keratosis. The agency first approved the microtubule inhibitor on Dec. 14, 2020. Dosing is one unit-dose packet on the face or scalp once daily for five consecutive days. Drugs.com lists the price of five packets of the ointment as more than $1,179.
June 10: The FDA gave another indication to Sanofi and Regeneron Pharmaceuticals, Inc.’s Kevzara (sarilumab) for the treatment of people weighing at least 63 kg with active polyarticular juvenile idiopathic arthritis. The agency initially approved the interleukin-6 (IL-6) receptor antagonist on May 22, 2017. The recommended dose is 200 mg via subcutaneous injection every two weeks. Drugs.com lists the price of both the 150 mg/1.14 mL and 200 mg/1.14 mL as more than $4,582.
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