European Commission approved Saphnelo to fight against systemic lupus erythematosus disease

Saphnelo launched by Astrazeneca has approved for the first time, in the European Union after United States in August. The pharmaceutical company defines it as a first in class type I interferon receptor antibody and the only medicine in over a decace for patients.

This therapy is dedicated to the treatment of adults patients with moderate to serve, active auto antibody-positive systemic lupus erythematosus called SLE. The disease is a serious and complex auto-immune condition for patients and affect any organ. It damages in a long term body and a quality of life from 1 to 3.

According to Astrazeneca’studies in Europe 250. 000 people suffured of systemic lupus erythematosus. Most of them patients diagnoticated are women from 15–45 year old. In USA, the SLE, the most common form of lupus affecting up to 300,000 people, disproportionately affects the African-American, Hispanic and Asian populations. It is a complex autoimmune condition that can affect any organ, and people often experience debilitating symptoms, long-term organ damage and poor health-related quality of life.

Saphnelo is under regulatory review for SLE in the EU and Japan. The Phase III trial in SLE using subcutaneous delivery has been initiated.Phase III trials are planned for lupus nephritis, cutaneous lupus erythematosus and myositis.

The approval by the European Commission was based on results from the Saphnelo clinical development programme, including the TULIP Phase III trials and the MUSE Phase II trial.5–7.

Across clinical 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.5–7 Minimising OCS use while reducing disease activity is an important treatment goal in SLE to reduce the risk of organ damage.8,9 The approval follows the recommendation by the Committee for Medicinal Products for Human Use of the European Medicines Agency in December 2021.

To clarify on what is done in Europe, Mr Ronald van Vollenhoven, Chair of Rheumatology and Director of the Amsterdam Rheumatology Center in Amsterdam, the Netherlands explained that

“In Europe, there have been limited treatment options for patients living with systemic lupus erythematosus and many patients face poor outcomes. Anifrolumab targets the type I interferon pathway, which is known to play a central role in lupus pathophysiology. Today’s approval is an important step forward in treating this disease.”

Mene Pangalos, Executive Vice President, BioPharmaceuticals R&D, AstraZeneca, added to

Saphnelo is the first new medicine for systemic lupus erythematosus to gain approval in Europe in over a decade and is the only biologic not restricted to patients with a high degree of disease activity. Saphnelo has demonstrated clinically meaningful benefits and we look forward to bringing it to patients as quickly as possible.”

The most frequent adverse reactions that occurred in patients who received Saphnelo in the controlled clinical trials included upper respiratory tract infection, bronchitis, infusion-related reactions and herpes zoster.5–7 . This new medecine was recently approved not only in the US but also in 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.

AstraZeneca is a global biopharmaceutical company based in Cambridge UK specialized in research : Oncology, Rare Diseases, and BioPharmaceuticals, Cardiovascular, Renal & Metabolism, and Respiratory & Immunology. It operates in over 100 countries and its innovative medicines are used by millions of patients worldwide.

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Hafida B

Hafida B

Journalist-writer, I do love photography for some events. I buy photos and content English/FR.