With Oxlumo Approval, Alnylam Unveils Value-Based Program

With its third FDA approval in less than two-and-a-half years, Alnylam Pharmaceuticals, Inc. is bringing another orphan drug for a rare condition to the U.S. market. And similar to the first two, Oxlumo (lumasiran) comes with a costly price tag. To help provide payers with some predictability around costs, the company is extending a new value-based agreement, as well as offering another VBA that the company introduced with its previous approval.

On Nov. 23, the FDA approved Alnylam’s Oxlumo for the treatment of primary hyperoxaluria type 1 (PH1) to lower urinary oxalate levels in pediatric and adult patients. The agency says it is the first treatment approved for the rare genetic disorder, in which the body overproduces oxalate. This, in turn, results in the deposition of calcium oxalate in the kidneys and urinary tract, which can lead to kidney stones, nephrocalcinosis, kidney failure and organ damage throughout the body.

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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