Saphnelo gets FDA nod for moderate to severe SLE

Anglo-Swedish pharma major AstraZeneca’s (LSE: AZN) Saphnelo (anifrolumab-fnia) has been approved in the USA for the treatment of adult patients with moderate to severe systemic lupus erythematosus (SLE) who are receiving standard therapy.

The approval by the Food and Drug Administration was based on efficacy and safety data from the Saphnelo clinical development program including two TULIP Phase III trials and the MUSE Phase II trial. In these trials, more patients treated with the drug experienced a reduction in overall disease activity across organ systems, including skin and joints, and achieved sustained reduction in oral corticosteroid (OCS) use compared to placebo, with both groups receiving standard therapy.

This marks the first regulatory approval for a type I interferon (type I IFN) receptor antagonist and the only new treatment approved for SLE in more than 10 years. It also comes 10 years after GlaxoSmithKline (LSE: GSK) gained FDA approval of its SLE treatment Benlysta (belimumab) in 2011, breaking almost 50 years of stagnation in this field.