Wedoany.com Report-Dec.17, The U.S. Food and Drug Administration has authorized GSK's medication Exdensur as an additional maintenance therapy for individuals aged 12 years and older with severe asthma featuring an eosinophilic phenotype. This marks the introduction of the first biologic option requiring only twice-yearly administration.

GSK indicated that the agency did not grant approval for Exdensur in treating chronic rhinosinusitis with nasal polyps, a persistent inflammatory condition affecting the sinuses.

"We remain confident in the benefit Exdensur could bring for patients with CRSwNP and are continuing discussions with the FDA," a GSK spokesperson told Reuters.

The approval for asthma relies on results from multiple advanced-stage clinical studies, including at least four trials. Two key studies demonstrated that adding the treatment to standard care lowered the frequency of asthma exacerbations and related hospitalizations in patients with this specific severe form.

Exdensur, known chemically as depemokimab, targets a protein involved in type 2 inflammation, helping to manage elevated eosinophil levels that contribute to airway issues.

This development occurs as GSK prepares for leadership transition, with current commercial head Luke Miels set to assume the chief executive role in the coming year. The company continues to advance its pipeline to introduce newer therapies addressing upcoming patent expirations on established products.

Market observers anticipate strong potential for the medication, viewing it as capable of achieving substantial sales, though its performance in studies aligns closely with current alternatives. Adoption may depend significantly on the appeal of its extended dosing interval for suitable patients.

The treatment positions itself alongside existing options such as Dupixent from Sanofi and Regeneron, Xolair from Roche and Novartis, and others that typically require administration every two to four weeks.

GSK anticipates that Exdensur could appeal to individuals who experience challenges adhering to more frequent regimens or those considering changes from other biologics.

Separately, the United Kingdom's regulatory authority recently authorized Exdensur for add-on use in asthma patients aged 12 and older, as well as for chronic rhinosinusitis with nasal polyps in adults.

This U.S. authorization enhances treatment choices for managing severe eosinophilic asthma, offering a convenient schedule that may improve patient experience while maintaining control over symptoms.

The twice-yearly approach represents an advancement in biologic delivery for respiratory conditions driven by type 2 inflammation pathways.

By providing sustained effects with fewer injections, the option supports ongoing efforts to optimize long-term management strategies for affected individuals.

Clinical evidence underscores reductions in acute events, contributing to fewer disruptions and better quality of daily life.

As additional regulatory reviews progress globally, Exdensur adds to evolving standards in targeted therapies for inflammatory respiratory disorders.

Overall, the approval reinforces focus on innovative dosing to meet practical needs in chronic disease care.