FDA Approves First New Drug for SLE in a Decade

The US Food and Drug Administration (FDA) has approved anifrolumab-fnia (Saphnelo) for treatment of moderate to severe systemic lupus erythematosus (SLE) among adult patients who are receiving standard therapy, according to an announcement by the drug’s manufacturer, AstraZeneca.

The agency’s action marks the first approval for a type I interferon (type I IFN) receptor antagonist, as well as the first approval for a new SLE therapy in more than 10 years.

FDA approved the drug on the basis of efficacy and safety data from the phase 2 MUSE trials and the phase 3 TULIP-1 and TULIP-2 trials. These randomized, double-blind, placebo-controlled trials were conducted among patients with SLE who were being treated with oral corticosteroids, antimalarial drugs, immunosuppressants such as methotrexate, azathioprine, or mycophenolate mofetil, or some combination of these therapeutics.

More patients treated with anifrolumab-fnia experienced reduced disease activity in skin, joints, and organ systems, and were able to sustain reduction in the use of oral corticosteroids than those receiving standard therapy.

—Rebecca Mashaw

Reference:

Saphnelo (anifrolumab) approved in the US for moderate to severe systemic lupus erythematosus. [Press release]. August 2, 2021. https://www.astrazeneca.com/content/astraz/media-centre/press-releases/2021/saphnelo-approved-in-the-us-for-sle.html. Accessed August 3, 2021.