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AstraZeneca

FDA Approves AstraZeneca Antibody for Lupus After Previous Rejection

August 4, 2021

Three years after it missed a key endpoint in its first phase 3 trial, AstraZeneca’s monoclonal antibody Saphnelo (anifrolumab-fnia) turned things around and has now garnered FDA approval for the treatment of adult patients with moderate-to-severe systemic lupus erythematosus (SLE), the most common form of lupus.

Saphnelo, administered by intravenous infusion, is the first interferon receptor antagonist to be approved for lupus patients and is also the first new treatment approved for this form of lupus since 2011, when the FDA greenlighted GlaxoSmithKline’s Benlysta (belimumab), which works by blocking the human B lymphocyte stimulator protein.

Saphnelo’s approval is only the third FDA approval of a new therapy across all types of lupus in 60 years, according to the Lupus Foundation of America.

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