Saphnelo Recommended for Approval in the EU by CHMP for the Treatment of Patients with Systemic Lupus Erythematosus

AstraZeneca’s Saphnelo (anifrolumab) has been recommended for marketing authorization in the European Union (EU) as an add-on therapy for the treatment of adult patients with moderate to severe, active autoantibody-positive systemic lupus erythematosus (SLE), despite receiving standard therapy. SLE is a complex autoimmune condition that can affect any organ, and people often experience inadequate disease control, long-term organ damage and poor health-related quality of life. If approved, Saphnelo would be the first new treatment for SLE in Europe in more than a decade.

The Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency based its positive opinion on results from the Saphnelo clinical development program, including the 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 and achieved sustained reduction in oral corticosteroid (OCS) use compared to placebo, with both groups receiving standard therapy.

Ian Bruce, Professor of Rheumatology at the University of Manchester, UK, and steering committee chair for the Saphnelo SLE clinical development program, said, “Systemic lupus erythematosus is a complex and heterogeneous disease that can have a debilitating impact on a person’s quality of life. We need new treatments that are effective in reducing underlying disease activity for patients, particularly those who require higher doses of oral corticosteroids, which themselves can be damaging in the long-term. The anifrolumab clinical program has provided compelling evidence that this medicine has the potential to be an important new option for patients.”

Mene Pangalos, Executive Vice President, BioPharmaceuticals R&D, AstraZeneca, said: “Saphnelo is a ground-breaking first-in-class medicine and offers physicians and patients a new way of treating systemic lupus erythematosus by targeting the type I interferon receptor, which is known to play a central role in lupus disease pathophysiology. This positive recommendation from the CHMP brings us one step closer to providing a much-needed new treatment option to improve outcomes for patients in Europe.”

The adverse reactions that occurred more frequently in patients who received Saphnelo in the three clinical trials included upper respiratory tract infection, bronchitis, infusion-related reactions and herpes zoster.