New FDA Approvals: FDA Expands Label of Novartis’ Leqvio

July 7: The FDA broadened the label of Novartis Pharmaceuticals Corp.’s Leqvio (inclisiran) to include its use as an adjunct to diet and statin therapy to reduce low-density lipoprotein cholesterol (LDL-C) in adults with primary hyperlipidemia. The agency initially approved the small interfering RNA (siRNA) therapy on Dec. 22, 2021. Dosing is 284 mg via a subcutaneous injection by a health care professional, then another dose at three months and then every six months. The drug’s list price is $3,290.63 per dose.

July 11: The FDA expanded the label of Organon’s Hadlima (adalimumab-bwwd) to include the treatment of adults with non-infectious intermediate and posterior uveitis and panuveitis. The agency first approved the biosimilar of AbbVie Inc.’s Humira (adalimumab) on July 23, 2019. Dosing starts with 80 mg via subcutaneous injection, followed by 40 mg every other week starting one week after the initial dose. The agent is available in both low-concentration and high-concentration versions of its reference drug. The product recently launched with a wholesale acquisition cost of $1,038 for a carton of two syringes or autoinjectors.

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Angela Maas

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.

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