In a battered field, AstraZeneca's lupus drug clears pivotal study — but can they get it approved now?
A year after AstraZeneca admitted defeat in a late-stage study testing its lupus drug anifrolumab, the British drugmaker has cleared their second pivotal trial, hitting the primary endpoint and leaving their research team hopeful that they have enough data in hand to get an approval.
Last year, anifrolumab failed to meet the main goal of diminishing disease activity in the 460-patient TULIP 1 study, a 52-week trial that tested two doses of the drug versus a placebo. But in the 373-patient TULIP II study, the higher dose (300 mg) was compared to patients given a placebo — and the study met the main goal of reducing disease severity.
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