Amgen posts ROCKET-SHUTTLE Phase 3 rocatinlimab results; Neulasta label updated; AMG 691 trial opens
Amgen's week included topline Phase 3 atopic dermatitis data, an FDA label supplement for Neulasta, and the start of a new Phase 1 trial in China and Japan.
Amgen had three routine registry and regulatory items this week spanning a completed Phase 3 study, a labeling update, and a newly recruiting early-phase trial.
- Amgen posted results for "ROCKET-SHUTTLE," a Phase 3 trial testing rocatinlimab in combination with topical corticosteroids and/or topical calcineurin inhibitors against placebo plus the same background therapy in adults with moderate-to-severe atopic dermatitis1. The study enrolled 746 participants1 and reached study completion on 2024-12-041, with results first posted 2026-08-06.
- The FDA approved a labeling supplement for Neulasta (pegfilgrastim). The supplement 210 was approved as a labeling submission, with the label dated 2026-08-11 and the submission status date 2026-08-042.
- Amgen began recruiting for a Phase 1 trial of AMG 691. The study is designed to evaluate the pharmacokinetics, safety, tolerability, and immunogenicity of AMG 691 in healthy Chinese and Japanese participants3, with an estimated enrollment of 28 participants3.
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