New FDA Approvals: FDA Approves Chiesi Group and Protalix’s Elfabrio

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June 8

May 9: The FDA approved Chiesi Group unit Chiesi Global Rare Diseases and Protalix BioTherapeutics, Inc.’s Elfabrio (pegunigalsidase alfa-iwxj) for the treatment of adults with Fabry disease. A PEGylated enzyme replacement therapy, the agent is a recombinant human α–Galactosidase–A enzyme expressed in plant-cell culture that is designed to provide a long half-life. Recommended dosing is 1 mg/kg via intravenous infusion every two weeks.

May 17: The FDA approved a 40 mg/0.8 mL single-dose autoinjector for Boehringer Ingelheim’s Cyltezo (adalimumab-adbm). The agency initially approved the biosimilar of AbbVie Inc.’s Humira (adalimumab) on Aug. 25, 2017, as a single-use prefilled syringe. The drug is approved for multiple chronic inflammatory diseases. The new pen will be available in two-, four- and six-pack options when the tumor necrosis factor (TNF) inhibitor launches on July 1.

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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 (formerly called Specialty Pharmacy News) since she joined AIS Health in 2005 and has broad knowledge of the various issues at play within the space. Before joining AIS Health, she was managing editor at Employee Benefit News and Employee Benefit News Canada and managing editor at HemAware (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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