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AZ’s Saphnelo receives EU approval for systemic lupus erythematosus

There are an estimated 250,000 people living with SLE in Europe and this is the first new drug to gain EU approval in over ten years

AstraZeneca

AstraZeneca’s (AZ) drug Saphnelo (anifrolumab) has been approved in the EU, allowing it to be used as an add-on therapy for the treatment of adult patients with moderate to severe systemic lupus erythematosus (SLE), despite receiving standard treatment.

The approval comes after a recommendation issued by the European Medicines Agency’s (EMA)  Committee for Medicinal Products for Human Use (CHMP) in December 2021.

SLE is a complex autoimmune condition that can affect any organ, with patients often experiencing inadequate disease management, long-term organ damage and a poor quality of life. In Europe, there are an estimated 250,000 people living with SLE, with most women diagnosed between the ages of 15 and 45.

Saphnelo is the only biologic SLE approved in Europe that is not restricted to only those patients who have a high degree of disease activity.

Ronald van Vollenhoven, chair of rheumatology and director of the Amsterdam Rheumatology Center in Amsterdam, the Netherlands said: “Anifrolumab targets the type 1 interferon pathway, which is known to play a central role in lupus pathophysiology.

“In Europe, there have been limited treatment options for patients living with systemic lupus erythematosus and many patients face poor outcomes,” he added.

The European Commission’s approval was based on data from the Saphnelo clinical development programme – including the TULIP phase 3 trials and the MUSE phase 2 trial.

One of the key treatment goals in SLE is to minimise the use of oral corticosteroids while reducing disease activity in order to reduce the risk of damage to the patient’s organs.

In the clinical trials, more patients treated with Saphnelo experienced a reduction in overall disease activity across organ systems, while being able to reduce their use of oral corticosteroid, than those in the placebo group.

Mene Pangalos, executive vice president, BioPharmaceuticals R&D, AstraZeneca, said: “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,” he added.

Article by
Fleur Jeffries

16th February 2022

From: Regulatory

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