Amgen, Kyowa Kirin Bolster Safety Profile for Atopic Dermatitis Drug Rocatinlimab

Amgen and Kyowa Kirin are jointly developing rocatinlimab, an investigational anti-OX40 receptor antibody for moderate to severe atopic dermatitis1 2 5.

Recent top-line results from the Phase 3 ASCEND trial, a long-term extension study with approximately 2,600 patients, confirm a favorable ongoing safety profile for rocatinlimab with up to 2.5 years of data1 3 5.

After an initial 24-week dosing period, rocatinlimab may allow for maintenance dosing as infrequently as every eight weeks, potentially reducing treatment burden for patients3 5.

Efficacy results from earlier studies in the ROCKET program show that over 40% of patients on the 300-mg dose achieved at least a 75% reduction in eczema area and severity index (EASI) after 24 weeks, though results are considered modest compared to Dupixent, the current market leader1 4.

Rocatinlimab's mechanism targets OX40R+ pathogenic T cells, aiming to address T-cell imbalance, a driver of chronic skin inflammation in atopic dermatitis2.

A regulatory filing for rocatinlimab is expected later in 2025, with a possible product launch in 20261.

Full trial results are planned for presentation at major scientific meetings, including the 2025 American Academy of Dermatology Annual Meeting2 5.