{"id":735,"date":"2025-12-17T23:36:17","date_gmt":"2025-12-18T07:36:17","guid":{"rendered":"https:\/\/getasecondopinion.ai\/blog\/?p=735"},"modified":"2025-12-22T14:57:17","modified_gmt":"2025-12-22T22:57:17","slug":"fda-approves-exdensur-a-twice-yearly-shot-that-could-change-life-for-people-with-severe-asthma","status":"publish","type":"post","link":"https:\/\/www.getasecondopinion.ai\/blog\/medications\/new-drugs\/fda-approves-exdensur-a-twice-yearly-shot-that-could-change-life-for-people-with-severe-asthma\/","title":{"rendered":"FDA Approves Exdensur: A Twice\u2011Yearly Shot That Could Change Life for People with Severe Asthma"},"content":{"rendered":"\n

Severe asthma can be frightening: sudden attacks, emergency visits, and daily limits on what you can do. On December 16, 2025, the U.S. Food and Drug Administration (FDA) approved Exdensur (depemokimab\u2011ulaa)<\/strong> as an add\u2011on maintenance treatment for people aged 12 and older with severe asthma characterized by an eosinophilic phenotype<\/strong>  –  a type of asthma driven by a specific immune cell called an eosinophil. This approval is notable because Exdensur is the first ultra\u2011long\u2011acting biologic that only needs two injections per year, offering a simpler schedule for patients who struggle with frequent dosing.<\/p>\n\n\n\n

What is Exdensur and why is this approval important?<\/strong><\/h2>\n\n\n\n

Exdensur<\/strong> is a biologic medicine developed by GSK that targets interleukin\u20115 (IL\u20115)<\/strong>, a protein that helps eosinophils survive and cause inflammation in the airways. By blocking IL\u20115, Exdensur reduces the number of eosinophils and lowers the risk of asthma attacks (exacerbations). What makes Exdensur stand out is its ultra\u2011long action: it\u2019s designed to be effective with just two injections a year, which could be a big deal for people who find monthly or biweekly shots hard to keep up with.<\/p>\n\n\n\n

Many people with severe asthma still have attacks despite inhalers and other medicines. Biologics have helped some of these patients, but uptake has been limited  –  partly because of frequent dosing and access issues. A twice\u2011yearly option could make it easier for more people to stay on treatment and avoid hospital visits.<\/p>\n\n\n\n

What the clinical trials showed<\/strong><\/h2>\n\n\n\n

Exdensur\u2019s FDA approval is based on two large Phase III trials called SWIFT\u20111<\/strong> and SWIFT\u20112<\/strong>. These were randomized, placebo\u2011controlled studies that added Exdensur to patients\u2019 usual asthma care and followed them for a year.<\/p>\n\n\n\n