{"id":645604,"date":"2026-10-05T16:30:11","date_gmt":"2026-10-05T16:30:11","guid":{"rendered":"https:\/\/www.newsbeep.com\/ie\/645604\/"},"modified":"2026-10-05T16:30:11","modified_gmt":"2026-10-05T16:30:11","slug":"european-commission-approves-new-treatment-for-severe-asthma","status":"publish","type":"post","link":"https:\/\/www.newsbeep.com\/ie\/645604\/","title":{"rendered":"European Commission approves new treatment for severe asthma"},"content":{"rendered":"

Exdensur (depemokimab) is the first and only ultra-long-acting biologic in the EU to treat severe asthma and chronic rhinosinusitis with nasal polyps<\/p>\n

Pharmaceutical company GSK Ireland has submitted an application to health officials here for reimbursement of a new treatment for severe asthma. Exdensur (depemokimab) was recently approved by the European Commission for severe asthma with type 2 inflammation and chronic rhinosinusitis with nasal polyps (CRSwNP). It is the first and only ultra-long-acting biologic indicated for these conditions in the EU.<\/p>\n

The approval is based on data from the SWIFT and ANCHOR phase III trials, which showed sustained efficacy with a twice-yearly dosing regimen for depemokimab. Each of the four trials met their primary or co-primary endpoints with statistically significant and clinically meaningful results, comparing the addition of depemokimab to standard of care versus standard of care alone.<\/p>\n

An application has been submitted to Ireland\u2019s Corporate Pharmaceutical Unit (CPU) and the National Centre for Pharmacoeconomics (NCPE) for potential reimbursement of the drug as an add on treatment for severe asthma with type 2 inflammation and chronic rhinosinusitis with nasal polyps.<\/p>\n

Prof Richard Costello, a consultant respiratory physician at Beaumont Hospital, described the medicine as \u2018a new era in innovation in asthma care\u2019.<\/p>\n

\u201cExdensur (depemokimab) promises to be a highly effective solution for patients with severe asthma by reducing the burden of medication use and providing meaningful clinical outcomes,\u201d he added.<\/p>\n

An estimated 450,000 people in Ireland currently have asthma, with around 900,000 individuals expected to develop the condition over their lifetime. Severe asthma is estimated to affect 3-10 per cent of the asthma population, and many patients with CRSwNP face inadequately controlled symptoms.<\/p>\n

The European Commission approved depemokimab in two indications. Firstly, as add-on maintenance treatment for severe asthma with type 2 inflammation characterised by blood eosinophil count in adults and adolescents 12 years and older who are inadequately controlled despite high dose inhaled corticosteroids (ICS) plus another asthma controller.<\/p>\n

The treatment has also been authorised as an add-on therapy with intranasal corticosteroids for the treatment of adult patients with severe CRSwNP for whom therapy with systemic corticosteroids and\/or surgery do not provide adequate disease control. \u201cFrom a patient perspective, timely access to licensed treatment options is an important part of improving quality of life and long-term health outcomes,\u201d said Asthma Society of Ireland CEO Eil\u00eds N\u00ed Chaithn\u00eda.<\/p>\n

\u201cWhile this medicine is already authorised for use, eligible Irish patients will eventually benefit from it, following the NCPE appraisal and when reimbursement arrangements are in place. We welcome ongoing progress between all stakeholders to ensure equitable and sustainable access for the people who need it.\u201d<\/p>\n

Kaivan Khavandi, SVP and global head of respiratory, immunology and inflammation R&D at GSK, said: \u201cThe approval of Exdensur (depemokimab) in the EU means there is now an innovative ultra-long-acting option that offers sustained efficacy over six months to protect patients from severe asthma exacerbations and the debilitating symptoms associated with CRSwNP. \u201cExdensur (depemokimab) may help redefine care for the millions of patients living with these persistent and burdensome conditions, supporting them in achieving their treatment goals with just two doses a year.\u201d <\/p>\n","protected":false},"excerpt":{"rendered":"Exdensur (depemokimab) is the first and only ultra-long-acting biologic in the EU to treat severe asthma and chronic…\n","protected":false},"author":2,"featured_media":645605,"comment_status":"","ping_status":"","sticky":false,"template":"","format":"standard","meta":{"footnotes":""},"categories":[10],"tags":[22744,106150,1712,106149,22989,103,61,60,129263,274128],"class_list":["post-645604","post","type-post","status-publish","format-standard","has-post-thumbnail","category-health","tag-asthma","tag-depemokimab","tag-european-commission","tag-exdensur","tag-gsk","tag-health","tag-ie","tag-ireland","tag-respiratory-medicine","tag-rhinosinusitis"],"_links":{"self":[{"href":"https:\/\/www.newsbeep.com\/ie\/wp-json\/wp\/v2\/posts\/645604","targetHints":{"allow":["GET"]}}],"collection":[{"href":"https:\/\/www.newsbeep.com\/ie\/wp-json\/wp\/v2\/posts"}],"about":[{"href":"https:\/\/www.newsbeep.com\/ie\/wp-json\/wp\/v2\/types\/post"}],"author":[{"embeddable":true,"href":"https:\/\/www.newsbeep.com\/ie\/wp-json\/wp\/v2\/users\/2"}],"replies":[{"embeddable":true,"href":"https:\/\/www.newsbeep.com\/ie\/wp-json\/wp\/v2\/comments?post=645604"}],"version-history":[{"count":0,"href":"https:\/\/www.newsbeep.com\/ie\/wp-json\/wp\/v2\/posts\/645604\/revisions"}],"wp:featuredmedia":[{"embeddable":true,"href":"https:\/\/www.newsbeep.com\/ie\/wp-json\/wp\/v2\/media\/645605"}],"wp:attachment":[{"href":"https:\/\/www.newsbeep.com\/ie\/wp-json\/wp\/v2\/media?parent=645604"}],"wp:term":[{"taxonomy":"category","embeddable":true,"href":"https:\/\/www.newsbeep.com\/ie\/wp-json\/wp\/v2\/categories?post=645604"},{"taxonomy":"post_tag","embeddable":true,"href":"https:\/\/www.newsbeep.com\/ie\/wp-json\/wp\/v2\/tags?post=645604"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}