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Saphnelo recommended for approval in the EU

AstraZeneca’s Saphnelo 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.

If approved, Saphnelo would be the first new treatment for SLE in Europe in more than a decade, states the company.

“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,” says Mene Pangalos, Executive Vice President, BioPharmaceuticals R&D, AstraZeneca.

Recently approved in the US, Japan and Canada

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 programme, 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.

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.

Saphnelo was recently approved in the US, Japan and Canada for the treatment of SLE, and regulatory reviews are ongoing in additional countries. The Phase III trial in SLE using subcutaneous delivery has been initiated and additional Phase III trials are planned for lupus nephritis, cutaneous lupus erythematosus and myositis.

Photo of Mene Pangalos: AstraZeneca