Kyowa Kirin to Regain Control of Rocatinlimab Development and Commercialization Program, Demonstrating Strong Commitment to Address High Unmet Medical Need in Atopic Dermatitis

Executive Summary

• Kyowa Kirin ends its development and commercialization collaboration with Amgen for rocatinlimab, regaining full control of the program.
• The company reaffirms commitment to advance rocatinlimab as a differentiated OX40‑targeted therapy for moderate‑to‑severe atopic dermatitis, with regulatory filing planned for H1 2026 (U.S. first).
• Phase 3 data from ROCKET‑IGNITE and ROCKET‑HORIZON demonstrated achievement of co‑primary and key secondary endpoints in ~1,500 adults; safety profile remains favorable.

Key Details

• Collaboration termination: Kyowa Kirin will assume all regulatory filings, future commercialization, and program management for rocatinlimab. Amgen will continue manufacturing the antibody.
• Strategic rationale: Amgen’s portfolio prioritization; Kyowa Kirin views rocatinlimab as a “key strategic priority.”
• Regulatory timeline: Planned U.S. regulatory submission in the first half of 2026, followed by Japan and other markets as appropriate.
• Phase 3 results (ROCKET‑IGNITE & ROCKET‑HORIZON):
• Enrolled ~1,500 adults with moderate‑to‑severe atopic dermatitis.
• Met all co‑primary endpoints: revised Investigator’s Global Assessment (rIGA) score of 0/1 (clear or almost clear skin).
• Met key secondary endpoints, satisfying U.S. regulatory requirements.
• Long‑term safety extension (ROCKET‑ASCEND): Demonstrated potential for sustained therapeutic effect; most frequent treatment‑emergent adverse events were upper respiratory infections, aphthous ulcers, headache, influenza, cough, and rhinitis. Results to be presented at an upcoming medical conference.
• Overall program scope: Phase 3 ROCKET program comprises eight pivotal studies covering adults, adolescents, systemic‑treatment‑naïve patients, and those previously treated with biologics or JAK inhibitors; >3,300 patients enrolled across the program.
• Additional indications under investigation: Moderate‑to‑severe uncontrolled asthma, prurigo nodularis, and other T‑cell imbalance–driven inflammatory conditions.

Notable Quotes

“Kyowa Kirin is confident in the potential of rocatinlimab to address critical unmet needs for patients with moderate-to-severe atopic dermatitis… We are excited to build on the strong clinical program we have established and apply our extensive clinical and commercial expertise…” – Abdul Mullick, President & COO, Kyowa Kirin

“Based on the data available to‑date, rocatinlimab has demonstrated a generally favorable benefit–risk profile across its Phase 3 clinical program… We will continue to evaluate rocatinlimab’s clinical profile as development progresses…” – Takeyoshi Yamashita, EVP & CMO, Kyowa Kirin