AstraZeneca’s Saphnelo has been approved by the U.S. FDA for the treatment of adult patients with moderate to severe systemic lupus erythematosus (SLE) — the most common form of lupus — becoming the only new medicine in over a decade for SLE patients.
The regulatory approval was based on efficacy and safety data from the Saphnelo clinical development programs, including two TULIP phase 3 trials and the MUSE phase 2 trial.
The approval was not without some controversial data. One of the drugmaker's phase 3 trials — Tulip-1 — missed its primary endpoint. But the second trial, Tulip-2, was a success — after the drugmaker switched how the trial measured disease reduction from the SLE Responder Index 4 (used in the Tulip-1) to the British Isles Lupus Assessment Group–based Composite Lupus Assessment.
GSK's Benlysta was the last drug to grab FDA approval in the field back, in 2011. Benlysta, however, is a human monoclonal antibody that binds to soluble BLyS, while AstraZeneca’s Saphnelo is a type I interferon receptor antagonist — making it the first drug in its class to get the regulatory OK.
AstraZeneca has chatted up Saphnelo’s blockbuster potential, given that SLE affects around 300,000 people in the U.S.
