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LONDON - GSK plc (LSE/NYSE: GSK) has announced the acceptance of regulatory filings in China and Japan for depemokimab, a new biologic treatment for asthma with type 2 inflammation and chronic rhinosinusitis with nasal polyps (CRSwNP). If approved, depemokimab would be the first biologic of its kind to offer a six-month dosing schedule, potentially improving patient adherence.
The filings are based on the positive outcomes of the SWIFT and ANCHOR phase III clinical trials. In the SWIFT trials, depemokimab demonstrated a significant reduction in exacerbation and hospitalization rates for asthma patients with type 2 inflammation when used as an add-on therapy. Similarly, the ANCHOR trials showed that depemokimab effectively reduced nasal polyp size and obstruction in CRSwNP patients compared to placebo.
Depemokimab, a monoclonal antibody targeting interleukin-5 (IL-5), represents a potential advancement in treating diseases characterized by type 2 inflammation. This inflammation, often identified by blood eosinophil count, is a common factor in many patients with severe asthma and CRSwNP, leading to exacerbations and hospitalizations.
The burden of asthma in China is significant, with an estimated 46 million adults affected, and approximately 15.5% have experienced an exacerbation requiring hospitalization in the last year. CRSwNP is also a prevalent condition, affecting up to 4% of the general population, with a substantial portion having uncontrolled disease.
The pharmaceutical company's global head of Respiratory/Immunology R&D, Kaivan Khavandi, expressed confidence in the potential of depemokimab to reduce the burden of both asthma and CRSwNP on patients and healthcare systems.
The depemokimab development program includes additional phase III trials for other IL-5 mediated diseases, indicating GSK's commitment to addressing respiratory conditions.
Asthma and CRSwNP are conditions that not only impact individuals' health but also impose a financial strain on healthcare systems due to the need for emergency interventions and hospital care. The development of depemokimab aligns with GSK's goal to redefine the future of respiratory medicine and improve outcomes for those affected by these conditions.
Currently, depemokimab has not been approved for use in any country, and the results of the ANCHOR trials are expected to be presented at a forthcoming scientific congress. The acceptance of depemokimab for review signifies a step forward in the treatment options available for patients with these inflammatory conditions, with the potential for improved quality of life and reduced healthcare costs.
This article is based on a press release statement from GSK.
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