GSK asthma treatment approved by US regulators

US regulators have approved GSK’s Exdensur treatment for severe asthma with an eosinophilic phenotype, marking the first ultra-long-acting biologic with twice-yearly dosing for this condition.

The Food and Drug Administration’s decision was based on clinical trial results which showed a “significantly lower rate of annualised asthma exacerbations” in patients receiving the treatment compared with a placebo.

An estimated 2m Americans live with severe asthma, half of which experience frequent exacerbations and hospitalisations requiring novel solutions.

The SWIFT trial showed reduced exacerbations requiring hospitalisation and/or emergency department visits with Exdensur, otherwise known as depemokimab.

"Physicians in the US now have the option to provide sustained protection from exacerbations for patients living with severe asthma with an eosinophilic phenotype in just two doses a year," said Kaivan Khavandi, senior vice president and global head of respiratory, immunology and inflammation R&D at GSK.

"Exdensur could redefine patient care and further establish the use of biologics for those who continue to experience exacerbations despite treatment."