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CHMP recommend Saphnelo for systematic lupus erythematosus

With approval, Saphnelo would be the first available treatment for systematic lupus erythematosus in Europe in over ten years.

Saphnelo (anifrolumab), a first-in-class type 1 interferon receptor antibody, has been recommended for marketing authorisation in the EU. The drug has been recommended as an add-on therapy for the treatment of adult patients with moderate-to-severe active autoantibody-positive systemic lupus erythematosus (SLE) alongside standard therapy.

AstraZeneca’s Saphnelo has demonstrated efficacy in reducing overall disease activity in patients with systemic lupus erythematosus. The European Medicine Agency’s Comittee for Medicinal Products for Human Use (CHMP) based its positive opinion on results from the Saphnelo clinical development programme, including the TULIP phase 3 trials and the MUSE phase 2 trial.

More patients treated with Saphnelo in these trials experienced a reduction in overall disease activity across organ systems and achieved sustained reduction in oral corticosteroid (OCS) use, compared to placebo. Both groups also received standard therapy.

Ian Bruce, Professor of Rheumatology at the University of Manchester and steering committee chair for the Saphnelo SLE clinical development programme 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 programme has provided compelling evidence that this medicine has the potential to be an important new option for patients.”

SLE is a complex autoimmune condition that can affect any bodily organs. Patients of SLE often experience inadequate disease control, long-term organ damage and poor health-related quality of life.

SLE is the most common type of lupus and is an autoimmune disease in which the immune system attacks its own tissues, causing widespread inflammation and tissue damage in the affected organs. If approved, Saphnelo would be the first new treatment for SLE in Europe in more than a decade.