Amgen's Sjögren's drug dazodalibep meets primary endpoint in Phase 3 trial

Amgen reported that its experimental therapy for Sjögren's disease, dazodalibep, achieved the primary goal in a late‑stage study.

The Phase 3 OASIZ 301 trial enrolled roughly 621 patients with moderate to severe systemic disease and showed a statistically significant reduction in disease activity across multiple organs by week 48, with benefits appearing as early as week four.

Safety outcomes were similar to placebo, with low discontinuation rates. The most common adverse events were mild colds, urinary tract infections, hypertension and infusion‑related reactions.

Analysts say the data clear the first regulatory hurdle and could lay the foundation for a multi‑billion‑dollar franchise, although at least one additional trial will be required before an FDA filing.