GSK Plc has received US approval for a new biologic to treat severe asthma, a disease driven high levels of white blood cells in the airwaves which can lead to inflammation and a shortness of breath. The Food and Drug Administration decision, announced on 16 December, will introduce a new drug to the market requiring dosing only twice per year. Exdensur (depemokimab) is a long-acting interleukin-5 (IL-5) antagonist. It prevents IL-5 from activating its receptor on eosinophils, thereby reducing an overproduction of the white blood cells. The drug is to be administered by subcutaneous injection.
In a prepared statement, GSK’s global respiratory executive Kaivan Khavandi argued that Exdensur could “redefine patient care and further establish the use of biologics for those who continue to experience exacerbations despite treatment.”
The current standard of care for severe asthma is inhaled corticosteroids plus a secondary treatment. According to GSK, Exdensur’s extended half-life will enable it to sustain the suppression of type 2 inflammation in patients - an underlying cause of the disease. The FDA approved the drug as an add-on maintenance treatment for severe asthma characterised by an eosinophilic phenotype in adults and younger patients from the age of 12. The approval was based on the results of two Phase 3 trials showing respectively, 58% and 48% reductions, in the rate of annualised asthma exacerbations over 52 weeks compared with a placebo. In addition, fewer patients taking the drug required hospitalisation than those on the placebo.
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