Amgen and Kyowa Kirin Report Positive Long-Term Safety Data for Atopic Dermatitis Drug

Amgen and Kyowa Kirin have announced encouraging long-term safety and efficacy results for their investigational antibody rocatinlimab in the treatment of atopic dermatitis. The data, derived from the Phase III ASCEND extension study, bolsters the drug's potential for regulatory approval and market launch.

Long-Term Safety Profile Established

The ASCEND trial, which enrolled approximately 2,600 patients who had completed the previous ROCKET program, demonstrated a favorable long-term safety profile for rocatinlimab. Over a 56-week period, encompassing 24 weeks of initial treatment and 32 weeks of long-term follow-up, the dropout rate was reported as "low" across all treated groups. Common side effects included upper respiratory infections, flu, aphthous ulcers, and cough.

Sustained Efficacy in Atopic Dermatitis Treatment

Patients who initially responded to rocatinlimab and continued treatment reported ongoing therapeutic benefits at the one-year mark. These improvements were observed across multiple measures, including skin clearance, itch reduction, and decreases in disease extent and severity. While specific data points were not disclosed in the topline readout, the results suggest rocatinlimab's potential for durable efficacy in managing atopic dermatitis symptoms.

Regulatory Filing and Market Outlook

Jefferies analysts, commenting on the results, expressed increased confidence in rocatinlimab's approvability. Despite the limited statistical details provided, the analysts noted that the trial succeeded in demonstrating durability of response. Amgen and Kyowa Kirin are expected to file for regulatory approval later this year, with analysts projecting a potential market launch in 2026.

The development of rocatinlimab represents a significant investment for both companies, with Amgen having committed $400 million upfront in 2021 to partner with Kyowa Kirin on the drug's development. As an anti-OX40 receptor antibody, rocatinlimab works by suppressing systemic and local inflammatory responses, potentially offering a new mechanism of action in the treatment of atopic dermatitis.