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AstraZeneca’s Saphnelo to be approved in Europe for lupus

The EMA is set to approve the first new treatment for systemic lupus erythematosus in Europe in more than a decade


Following approval by the US Food and Drug Administration (FDA) in the late summer, AstraZeneca’s Saphnelo (anifrolumab) is set to be available to patients in Europe following a positive opinion from the Committee for Medicinal Products for Human Use (CHMP).

The committee has recommended the monoclonal antibody to the European Medicines Agency (EMA) as an add-on treatment for moderate-to-severe systemic lupus erythematosus (SLE).

SLE is the most common form of lupus affecting approximately 250,000 people in Europe, especially women who are diagnosed between the ages of 15 and 45.

A complex autoimmune condition, SLE can affect any organ and, if uncontrolled, can lead to long-term organ damage and poor health-related quality of life.

“Systemic lupus erythematosus is a complex and heterogeneous disease that can have a debilitating impact on a person’s quality of life,” said Professor of rheumatology Ian Bruce, from the University of Manchester, UK. “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,” he added.

Anifrolumab is a selective immunosuppressant that binds to sub-unit 1 of the type I interferon receptor blocking the biologic activity of type I interferons, which are cytokines involved in regulating the inflammatory pathways implicated in SLE.

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

The positive recommendation from the CHMP was based on three trials including the pivotal TULIP (Treatment of Uncontrolled Lupus via the Interferon Pathway) phase 3 programme. In TULIP-2, Saphnelo demonstrated superiority across multiple efficacy endpoints versus placebo.

Saphnelo is available as an infusion but AstraZeneca is running a phase 3 trial to assess the antibody as a subcutaneous injection.

In addition to a long-term extension phase 3 trial in SLE, the potential of Saphnelo is being explored in a variety of diseases in which type I interferon plays a key role, including lupus nephritis, cutaneous lupus erythematosus and myositis.

Article by
Hugh Gosling

21st December 2021

From: Regulatory



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