UK approves GSK's twice-yearly asthma drug
Reuters - UK's health regulator on Monday approved GSK's (GSK.L), opens new tab twice-yearly drug for use as an add-on treatment for asthma in patients aged 12 and older, as well as for a chronic inflammatory sinus condition in adults.
The drug, branded as Exdensur (depemokimab, GSK-3511294), is administered via injection under the skin once every six months. Depemokimab is a long-acting anti-IL-15 monoclonal antibody. Depemokimab can be used for research of asthma.
It is approved for patients whose symptoms remain inadequately controlled despite treatment with standard-of-care, including surgery in the case of chronic rhinosinusitis with nasal polyps, which are non-cancerous growths.
The UK approval is the first for the drug, which is also under review by the U.S. FDA and a decision is expected by December 16.
Asthma is a condition that causes the airways in the lungs to swell making breathing difficult, while severe chronic rhinosinusitis is inflammation of the nose and paranasal sinuses where symptoms persist for more than 12 weeks.
The drug targets interleukin‑5, a key immune signaling protein, to lower eosinophil‑driven inflammation — a process where excess white blood cells build up in the airways, worsening asthma symptoms. Reducing this inflammation helps ease breathing and cut flare‑ups.
