New FDA Specialty Approvals

July 7: The FDA approved Astex Pharmaceuticals, Inc., Taiho Oncology, Inc. and Otsuka Pharmaceutical Co., Ltd.’s Inqovi (decitabine and cedazuridine) for the treatment of adults with intermediate and high-risk myelodysplastic syndromes. The agency gave the application priority review and orphan drug designation. Review of the application was done in collaboration with agency counterparts in Canada and Australia through Project Orbis (RSP 10/19, p. 12). Dosing is one tablet once daily on days one through five of each 28-day cycle. Taiho Oncology will commercialize the drug in the U.S. Its launch is pending. Visit www.inqovi.com.

July 9: The FDA approved Mylan N.V. and Fujifilm Kyowa Kirin Biologics Co., Ltd.’s Hulio (adalimumab-fkjp) for the treatment of rheumatoid arthritis, juvenile idiopathic arthritis, psoriatic arthritis, ankylosing spondylitis, adult Crohn’s disease, ulcerative colitis and plaque psoriasis. The agency approved the biosimilar of AbbVie Inc.’s Humira (adalimumab) — the sixth one that the agency has approved — in both prefilled syringe and auto-injector presentations. Dosing varies depending on the indication. A patent license agreement with AbbVie will allow the drug to launch in the U.S. in 2023. Visit https://bit.ly/2DnyjOZ.

© 2024 MMIT
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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