Pharmaceutical Application Submitted for Exdensur Reimbursement in Ireland
Pharmaceutical company GSK Ireland has submitted an application to health officials for the reimbursement of Exdensur, known generically as depemokimab, as an add-on treatment for severe asthma and chronic rhinosinusitis with nasal polyps. The European Commission recently approved the medication for severe asthma with type 2 inflammation and chronic rhinosinusitis with nasal polyps, making it the first and only ultra-long-acting biologic indicated for these conditions within the European Union.
Clinical Trial Data Supporting the Biologic
The European Commission approval relies on data from the SWIFT and ANCHOR phase III clinical trials. These trials evaluated a twice-yearly dosing regimen of depemokimab as an add-on to the standard of care. Each of the four trials met primary or co-primary endpoints, demonstrating statistically significant and clinically meaningful results when compared against standard care alone. The therapy is designed to provide sustained efficacy over a six-month period per dose.
Regulatory Review and National Submissions
GSK Ireland submitted the reimbursement dossier to the Corporate Pharmaceutical Unit and the National Centre for Pharmacoeconomics. Eilís Ní Chaithnía, CEO of the Asthma Society of Ireland, noted that eligible patients will gain access following the completion of the National Centre for Pharmacoeconomics appraisal and the finalization of reimbursement arrangements. Kaivan Khavandi, senior vice president and global head of respiratory, immunology and inflammation R&D at GSK, stated that the twice-yearly dosing schedule aims to help patients achieve treatment goals while protecting them from severe exacerbations.
Impact on Severe Asthma Patients
Prof Richard Costello, a consultant respiratory physician at Beaumont Hospital, described the treatment as a new era in innovation for asthma care, noting it will reduce the burden of medication use. In Ireland, an estimated 450,000 people currently live with asthma, with approximately 900,000 individuals expected to develop the condition over their lifetime. Severe asthma accounts for an estimated 3 to 10 percent of the total asthma population, and many patients with chronic rhinosinusitis with nasal polyps experience symptoms that remain inadequately controlled by existing therapies.
Frequently Asked Questions
What specific conditions does Exdensur treat?
The European Commission approved depemokimab as an add-on maintenance treatment for severe asthma with type 2 inflammation characterized by blood eosinophil counts in adults and adolescents aged 12 and older who remain inadequately controlled on high-dose inhaled corticosteroids plus another controller. It is also authorized for severe chronic rhinosinusitis with nasal polyps in adults who lack adequate disease control from systemic corticosteroids or surgery.
How often is Exdensur administered?
Depemokimab functions as an ultra-long-acting biologic requiring a twice-yearly dosing regimen, providing patients with sustained efficacy over six months from each dose.
Which health bodies are reviewing the reimbursement application?
GSK Ireland submitted the reimbursement application to Ireland’s Corporate Pharmaceutical Unit and the National Centre for Pharmacoeconomics for evaluation as an add-on treatment.