Overview
- The FDA approved AstraZeneca’s Saphnelo Pen autoinjector for adults with systemic lupus erythematosus who are on standard therapy.
- The Phase 3 TULIP-SC trial showed that weekly subcutaneous dosing reduced disease activity compared with placebo in patients with moderate to severe disease.
- Safety results for the injection were consistent with the known profile of the intravenous formulation already in use.
- The new option lets many patients dose at home, which can reduce clinic infusion visits and make treatment easier to access.
- Subcutaneous use is already authorized in the European Union and Japan, while the IV form is approved in more than 70 countries with over 40,000 patients treated globally.