FDA Approves Once-Weekly Saphnelo Autoinjector for Systemic Lupus Erythematosus

FDA approves once-weekly Saphnelo autoinjector for systemic lupus erythematosus

The FDA has approved a self-administered autoinjector form of anifrolumab for the treatment of systemic lupus erythematosus, according to press release from the manufacturer.The anifrolumab (Saphnelo, AstraZeneca) autoinjector, dubbed the Saphnelo Pen, has been approved for once-weekly use alongside standard therapy. The drug, a type I interferon receptor antagonist, was first approved in IV form

FDA approves AstraZeneca’s Saphnelo for SLE

AstraZeneca has received approval from the FDA for the subcutaneous self-administration of Saphnelo using the Saphnelo pen for SLE.The post FDA approves AstraZeneca’s Saphnelo for SLE appeared first on Hospital Management.

AstraZeneca secures FDA approval for Saphnelo autoinjector to expand treatment access for lupus patients in the United States

AstraZeneca secures FDA approval for Saphnelo autoinjector to expand treatment access for lupus patients in the United States (IN BRIEF) AstraZeneca has secured FDA approval for a new subcutaneous autoinjector version of Saphnelo, enabling once-weekly self-administration for adults with systemic lupus erythematosus. The approval is based on Phase III trial results showing significant reductions in disease activity compared to placebo, with a saf…

Saphnelo approved in the US for subcutaneous self‑administration

Greater flexibility for people with systemic lupus erythematosus

FDA Approves AstraZeneca’s Saphnelo Pen For Self-administration In SLE

AstraZeneca plc (LON:AZN) Saphnelo (anifrolumab) has been approved in the US for self-administration as a once-weekly autoinjector, the Saphnelo Pen, for the treatment of adult patients with systemic lupus erythematosus (SLE) on top of standard therapy. The approval by the US Food and Drug Administration (FDA) was based on results from the Phase III TULIP-SC trial, which showed that subcutaneous (SC) administration of Saphnelo led to a statistic…