AstraZeneca’s Saphnelo to Compete with GSK’s Benlysta to Treat Lupus

The FDA approved anifrolumab-fnia (Saphnelo, AstraZeneca), a first-in-class treatment for adults with moderate to severe systemic lupus erythematosus (SLE) who are receiving standard therapy.

The FDA approval 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 SAPHNELO 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. Type I IFN plays a central role in the pathophysiology of lupus and increased type I IFN signaling is associated with increased disease activity and severity.

SLE, the most common form of lupus affecting up to 300,000 people in the US, disproportionately affects the African-American, Hispanic and Asian populations. It is a complex autoimmune condition that can affect any organ, and people often experience debilitating symptoms, long-term organ damage and poor health-related quality of life.

The FDA approved Benlysta as the first medicine for adult patients with active lupus nephritis in the U.S. Sales of Benlysta in the year 2020 were up 17% AER, 19% CER to £719 million, including sales of the sub-cutaneous formulation of £354 million up 32% AER, 33% CER.

Saphnelo offers a HCP-administered option with a novel mechanism of action. Both Saphnelo and Benlysta are administered IV every 4 weeks in adults. Benlysta IV is also approved for SLE in pediatrics ≥ 5 years of age and a SC formulation is also approved for use in adults. Several other products with varying mechanisms of action are also in phase 3 trials for SLE. A SC formulation of Saphnelo for SLE is in development.

Takeaway: Saphnelo, while primarily available through the leading specialty drug distributors, is also available through Amber Specialty Pharmacy and US Bioservices