Saphnelo recommended for approval by CHMP for the treatment of patients with systemic lupus erythematosus.
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 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.
Ian Bruce, Professor of Rheumatology at the University of Manchester, UK, 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.”
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