New lupus endpoint key to Phase III success for AZ’s anifrolumab

AstraZeneca's positive data for anifrolumab is the first successful Phase III trial in lupus in about a decade. But a previous Phase III failure for the mAb on a different endpoint leaves the pharma unable to commit to a timeline for regulatory submission just yet.

On Thursday, AstraZeneca plc (LSE:AZN; NYSE:AZN) announced top-line data from the 373-patient Phase III TULIP 2 that showed treatment with 300 mg anifrolumab every four weeks plus standard of care (SOC) led to a statistically significant improvement in the composite endpoint of BICLA response at week 52 vs. placebo plus SOC...