New FDA Approvals: FDA Expanded Almirall’s Klisyri Treatment Area

Jul 11
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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Angela Maas

Angela has an extensive background of editing, reporting and writing for trade and consumer publications. She has written Radar on Specialty Pharmacy since she joined AIS Health in 2005 and has broad knowledge of the various issues at play within the space. She also has written for Spotlight on Market Access since its 2017 launch. Before joining AIS Health, she was managing editor at Employee Benefit News and Employee Benefit News Canada and managing editor at Hem Aware (a hemophilia publication), Lupus Living and Momentum (a multiple sclerosis publication). She has a B.A. in English and an M.A. in British literature from Arizona State University.