Amgen Announces Positive Phase 3 Clinical Results and FDA Labeling Update

Amgen reported that its Phase 3 OASIZ-301 study of dazodalibep met its primary endpoint, significantly improving Sjögren’s disease symptoms at Week 48; full results are expected at an upcoming industry conference. Its Phase 3 TEPEZZA study in Japanese patients with chronic thyroid eye disease met both primary endpoints, with a safety profile consistent with established data. The FDA also approved updated IMDELLTRA labeling that shortens monitoring after the first two doses from 22–24 hours to 6–8 hours in appropriate healthcare settings. The article did not report financial results or stock-price movements.