On December 11, 2024, the U.S. Food and Drug Administration granted full approval to GlaxoSmithKline’s Depemokimab, a long-acting anti-IL-5 monoclonal antibody for severe eosinophilic asthma. The decision follows positive data from the Phase III DREAMM-AIR trial, which demonstrated significant reductions in exacerbation rates and sustained eosinophil suppression over 24 weeks.

Unlike existing biologics that require biweekly or monthly injections, Depemokimab offers a once-every-three-month dosing schedule, improving patient adherence and reducing treatment burden. The approval marks a major step forward for patients with high eosinophil counts who remain symptomatic despite standard inhaled therapies.

“This is a pivotal moment for severe asthma care,” said Dr. Marissa Chen, lead investigator of the DREAMM-AIR trial. “Depemokimab’s durability and targeted mechanism offer a new level of disease control for patients who’ve exhausted conventional options.”

The approval also reflects broader trends in rare disease drug development. In 2024, the FDA approved more than 20 orphan-designated therapies, many of which emerged from accelerated pathways and adaptive trial designs. Depemokimab’s success underscores the growing role of precision immunology in respiratory medicine and the value of biomarker-driven enrollment strategies.

GSK plans to launch Depemokimab in Q1 2025, with pricing and access programs tailored for underserved populations. BiopharmaWire will continue tracking its rollout and post-marketing surveillance data as it enters real-world use.