Amgen's Dazodalibep Shines in Sjögren's Disease Trial
Amgen's anti-CD40L drug dazodalibep has shown promise in treating Sjögren's disease (SjD), a debilitating autoimmune disorder that causes dryness and organ damage. The company announced that its phase 3 trial, OASIZ 301, met its primary objective of reducing systemic disease activity at week 48, as measured by the EULAR Sjögren's Syndrome Disease Activity Index (ESSDAI).
The results are significant because there is currently no FDA-approved medicine for SjD. Patients typically manage their symptoms with artificial tears and saliva substitutes, painkillers, and immunosuppressant drugs. Amgen acquired dazodalibep as part of its near-$28 billion takeover of Horizon Pharma in 2023.
Amgen's head of R&D, AI, and data, Jay Bradner, expressed confidence in the drug's potential to deliver a new treatment option for people living with SjD. The disorder affects about 1% of the global population and predominantly affects women.