AstraZeneca's Saphnelo gets approval in EU for systemic lupus erythematosus
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AstraZeneca's (NASDAQ:AZN) Saphnelo was approved in the EU as an add-on therapy to treat adult patients with moderate to severe, active autoantibody-positive systemic lupus erythematosus (SLE), despite receiving standard therapy.
The British drugmaker said Saphnelo (anifrolumab) is the first biologic for SLE approved in Europe with an indication that is not restricted to patients with a high degree of disease activity.
SLE is an autoimmune disease in which the immune system attacks its own tissues, which leads to inflammation and tissue damage in the affected organs. The company said there are ~250K people with SLE in Europe, and most are women who are diagnosed between the ages of 15 and 45.
The approval by the European Commission was backed by data from the Saphnelo development program, including TULIP phase 3 trials and the MUSE phase 2 study.
The drug was recommended for approval by the Committee for Medicinal Products for Human Use of the European Medicines Agency in December 2021.
Saphnelo is already approved in the U.S., Japan, and Canada.
In 2004, AstraZeneca acquired global rights to Saphnelo through a license deal with Medarex, which was acquired by Bristol-Myers Squibb (NYSE:BMY) in 2009. Under the agreement, AstraZeneca will pay BMS a low to mid-teens royalty for sales dependent on geography.
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