EU Approves GSK's New Asthma Drug Exdensur

The European Commission has approved GSK’s Exdensur for the treatment of severe asthma and chronic rhinosinusitis with nasal polyps, expanding access to the therapy across European Union countries, pharmaphorum reports. The decision follows the medication’s prior authorization in the UK and Japan for the same indications, as well as in the US for the treatment of severe asthma.

According to the company, the approval adds approximately 3 million potential patients to the target population, with a regulatory decision expected in China later this year. Exdensur belongs to the class of IL-5 inhibitors, similar to GSK’s established Nucala therapy, but offers the advantage of being administered only twice a year, whereas Nucala is administered monthly.

In the European Union, the drug is approved as an add-on maintenance treatment for patients aged 12 and older with severe type 2 inflammation asthma that is not adequately controlled by high-dose corticosteroids and additional treatment. For chronic rhinosinusitis with nasal polyps, the medication can be used as an adjunct to intranasal corticosteroids in patients for whom systemic treatment or surgery does not provide sufficient control.

GSK expects the drug to become one of the primary drivers of the company’s future growth, with forecasts suggesting potential peak annual sales of up to approximately £3 billion upon approval for all planned indications. Following the announcement of the decision, the company’s shares rose by approximately 2%.