In the News
The Food and Drug Administration has approved AstraZeneca’s drug Saphnelo for the treatment of systemic lupus, the British pharma announced Monday, making the antibody the first new drug cleared for the autoimmune condition since GlaxoSmithKline won approval for Benlysta in 2011. Saphnelo is the first drug of its type, designed to block an immune-activating protein called type 1 interferon.
Approval came despite Saphnelo failing one of two pivotal trials that aimed to show treatment could reduce disease activity and organ damage in patients. The FDA often requires drugs to have two successful trials before granting final approval for a drug.
Patient advocacy groups supported the FDA’s decision, which comes six months after the agency cleared another drug, Aurinia Pharmaceuticals’ Lupkynis, for a kind of kidney disease caused by lupus.
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