Wedoany.com Report-Dec.16, The UK's Medicines and Healthcare products Regulatory Agency announced on Monday the approval of GSK's injectable therapy, Exdensur, for two indications. The treatment is authorized as an additional option for patients aged 12 and older with severe asthma whose symptoms are not adequately managed by existing standard therapies. It is also approved for adults with chronic rhinosinusitis with nasal polyps, a persistent inflammatory condition, where symptoms continue despite prior medical treatment and, where applicable, surgical intervention.

Exdensur is administered subcutaneously once every six months, offering a convenient dosing schedule compared to more frequent regimens.

The medication works by targeting interleukin-5, an important signaling protein in the immune system. This action reduces eosinophil-related inflammation, characterized by elevated levels of certain white blood cells that contribute to airway obstruction in asthma and tissue swelling in chronic rhinosinusitis.

In severe asthma, this mechanism helps improve breathing and decrease the frequency of exacerbations. For chronic rhinosinusitis with nasal polyps—non-cancerous growths in the nasal passages—the therapy addresses ongoing inflammation of the nose and sinuses that lasts beyond 12 weeks.

This decision marks the first regulatory approval worldwide for Exdensur. The treatment is currently under evaluation by the U.S. Food and Drug Administration, with an expected decision on or around December 16, 2025.

Asthma affects the airways, causing swelling and narrowing that leads to breathing difficulties. Severe forms require multiple controller medications to maintain control. Chronic rhinosinusitis with nasal polyps involves prolonged symptoms such as nasal congestion, reduced sense of smell, and facial pressure, significantly impacting quality of life.

GSK's development of Exdensur focuses on biologic therapies that address specific inflammatory pathways, providing targeted relief for patients who respond inadequately to conventional options. The twice-yearly administration aims to support adherence and long-term management.

This approval expands treatment choices in respiratory and ear-nose-throat medicine, particularly for individuals with eosinophilic-driven conditions. Clinical data demonstrated meaningful improvements in symptom control and disease markers for both indications.

The UK's early authorization positions the therapy as a new tool for specialists managing complex cases. Ongoing reviews in other regions will determine broader availability.