New FDA Specialty Approvals

Dec. 14: The FDA approved a new dosing time for Roche Group unit Genentech USA, Inc.’s Ocrevus (ocrelizumab) to treat adults with relapsing forms of multiple sclerosis, including clinically isolated syndrome, relapsing-remitting disease and active secondary progressive disease, as well as primary progressive MS. Twice-yearly dosing via a shorter two-hour infusion is now available for people who have not experienced any serious infusion reactions. The initial dose is administered as two 300 mg two-and-a-half-hour infusions two weeks apart and then subsequent doses are 600 mg every six months. The agency initially approved the drug for subsequent infusions of three-and-a-half hours. The drug’s annual list price is $65,000, according to its website. Visit www.ocrevus.com.

Dec. 16: The FDA approved MacroGenics, Inc.’s Margenza (margetuximab-cmkb) in combination with chemotherapy for the treatment of adults with metastatic human epidermal growth factor receptor 2-positive breast cancer who have received at least two anti-HER2 regimens, with at least one of them for metastatic disease. Dosing is via a 120-minute intravenous infusion at 15 mg/kg for the first dose and then over a minimum of 30 minutes every three weeks. The company says it expects the drug to be available in March. Visit www.margenza.com.

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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