UK Approves First Twice-Yearly Asthma and CRSwNP Biological Medicine by GSK

The UK Medicines and Healthcare products Regulatory Agency (MHRA) has approved GSK’s depemokimab, branded as Exdensur, marking the first twice-yearly biological medicine option for adults and adolescents with asthma and severe chronic rhinosinusitis with nasal polyps (CRSwNP). This approval serves as a significant stride for patients whose symptoms persist despite conventional therapies, offering new hope for improved quality of life.

Asthma affects over 42 million individuals across Europe, with severe cases impacting a significant minority who continue to suffer despite existing treatment options. GSK’s depemokimab represents a noteworthy advancement in addressing this gap. The drug’s twice-yearly dosing regimen, validated through robust SWIFT and ANCHOR phase III clinical trials, has demonstrated remarkable efficacy. Results showed a 54% reduction in asthma attacks and a 72% decrease in exacerbations necessitating emergency visits. Moreover, the trials indicated substantial improvements in nasal obstruction symptoms for CRSwNP patients. Endorsements from the Committee for Medicinal Products for Human Use of the European Medicines Agency further enhance the drug’s credibility, with approval expected next year.

Depemokimab’s UK approval as a twice-yearly asthma and CRSwNP treatment heralds a new era in patient care, emphasizing GSK’s commitment to addressing the unmet needs of those with severe symptoms. By significantly curbing asthma attacks and nasal obstruction, this innovation stands to transform treatment paradigms, offering renewed optimism for enduring relief from debilitating conditions.