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AstraZeneca PLC on Friday said Saphnelo subcutaneous self-administration has been recommended for approval in the European Union for systemic lupus erythematosus. The green light came from the Committee for Medicinal Products for Human Use of the European Medicines Agency which based its positive opinion on interim results from the phase III Tulip-SC trial. This showed that subcutaneous 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 infusion. Shares in AstraZeneca, the Cambridge, England-based pharmaceuticals firm, closed up slightly at 12,558.00 pence each in London on Friday. Systemic lupus erythematosus is an autoimmune disease, where the immune system of the body mistakenly attacks healthy tissue. It can affect the skin, joints, kidneys, brain, and other organs. Ruud Dobber, executive vice president, BioPharmaceuticals at AstraZeneca, said: ‘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.’ Dobber said AstraZeneca is also advancing a 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. 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. Copyright 2025 Alliance News Ltd. All Rights Reserved.
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