AstraZeneca Saphnelo subcutaneous self-administration recommended for approval in EU by CHMP for systemic lupus erythematosus

The Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency based its positive opinion on interim results from the Phase III TULIP-SC trial, which showed that subcutaneous (SC) administration of Saphnelo led to a statistically significant and clinically meaningful reduction in disease activity compared to placebo in participants with moderate to severe, active, autoantibody-positive SLE while receiving standard therapy. The safety profile observed was consistent with the known clinical profile of Saphnelo administered as an intravenous (IV) infusion.

Professor Thomas Dörner, Rheumatologist and Professor of Rheumatology and Hemostaseology at Charité University Hospital, Berlin, Germany and investigator of the TULIP-SC trial said, “The positive recommendation for the subcutaneous administration of anifrolumab in the EU is highly encouraging for people living with systemic lupus erythematosus, as many still rely on oral corticosteroids, which carry significant side effects and are known to accelerate damage and functional impairment. With the latest treatment recommendations for SLE now placing increased importance on the use of biologics and earlier intervention to target remission while minimising steroids, a subcutaneous form of anifrolumab has the potential to offer broader access for patients.”

Ruud Dobber, Executive Vice President, BioPharmaceuticals Business Unit, AstraZeneca, said, “Saphnelo IV infusion has already helped transform outcomes for many patients with systemic lupus erythematosus. With this positive CHMP recommendation, we're one step closer to offering the clinically meaningful benefits of Saphnelo to more people in a convenient, once-weekly self-administration option. We are also advancing a robust development programme to explore Saphnelo’s potential in other diseases where type 1 interferon plays a central role, including cutaneous lupus erythematosus, lupus nephritis, myositis and systemic sclerosis.”

SLE is a debilitating autoimmune condition impacting more than 3.4 million people globally. It primarily affects women and can cause pain, rashes, fatigue, swelling in joints and fevers. In Europe, people with SLE have a two to three times increased risk of death compared to the overall population. While oral corticosteroids are often used to provide relief from SLE symptoms, they are associated with adverse events and do not target the underlying drivers of the disease. Approximately 70% of people in Europe who are on biologic therapy for SLE are already receiving a subcutaneous administration option.

Subcutaneous administration of Saphnelo is under regulatory review in several other countries around the world. Saphnelo IV infusion is approved for the treatment of moderate to severe SLE in more than 70 countries worldwide including the US, EU and Japan, with regulatory reviews ongoing in other countries. To date, more than 40,000 patients globally have been treated with Saphnelo.

AstraZeneca acquired global rights to Saphnelo through an exclusive license and collaboration agreement with Medarex, Inc. in 2004. The option for Medarex to co-promote the product expired on its acquisition by Bristol-Myers Squibb (BMS) in 2009. Under the agreement AstraZeneca will pay BMS a low to mid-teens royalty for sales dependent on geography.