The Priority Review

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OASIZ-301

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  1. Clinical trials

    Amgen announces positive Phase 3 results for dazodalibep in Sjögren's disease

    Amgen said the Phase 3 OASIZ-301 study met its primary endpoint, with both 1,500 mg every four weeks and 3,000 mg every 12 weeks regimens showing statistically significant reductions in ESSDAI score versus placebo at Week 48. The company noted improvements in patient-reported dryness and that the most common adverse events were nasopharyngitis, urinary tract infection, hypertension and infusion-related reactions.