GSK wins US approval for twice-yearly asthma drug
The U.S. health regulator has approved GSK’s (GSK.L), opens new tab add-on treatment for severe asthma, offering a less frequently dosed option, but rejected its use for another condition, the drugmaker said on Tuesday.
The U.S. Food and Drug Administration’s decision comes as GSK’s commercial chief Luke Miels prepares to take over as CEO early next year, with the drugmaker facing U.S. tariffs and seeking new medicines to offset patent expiries.
The FDA approved Exdensur as an add-on maintenance treatment for patients aged 12 and older with severe eosinophilic asthma, making it the first biologic cleared for twice-yearly dosing.
GSK said the FDA declined to approve the drug for the treatmeant of chronic rhinosinusitis with nasal polyps, a chronic inflammatory sinus condition.
“We remain confident in the benefit Exdensur could bring for patients with CRSwNP and are continuing discussions with the FDA,” a GSK spokesperson told Reuters.
The UK’s health regulator on Monday approved the drug, branded as Exdensur, for use as an add-on treatment for asthma in patients aged 12 and older, as well as for chronic rhinosinusitis with nasal polyps in adults.
The company’s FDA application included data from at least four late-stage trials, two of which showed the drug reduced asthma attacks and hospitalisations in patients with a form of severe asthma when added to standard treatment.
While analysts project the drug could become a blockbuster, they caution it has shown similar efficacy to existing treatments in trials and that its success hinges on patient uptake of the twice-yearly dosing.
GSK has said the drug could attract patients who discontinue existing biologic treatments or switch therapies, and expects it to become a major growth driver by the end of the decade.
The drug, chemically known as depemokimab, is expected to compete with Sanofi (SASY.PA), opens new tab and Regeneron’s (REGN.O), opens new tab Dupixent, Roche (ROG.S), opens new tab and Novartis'(NOVN.S), opens new tab Xolair – all dosed every two to four weeks.
