U.S. FDA approves GSK’s twice-yearly asthma drug

The U.S. health regulator has approved GSK’s add-on drug to treat severe asthma, the drugmaker said on Tuesday, paving the way for a less frequently dosed treatment option for patients to enter the market.

The Food and Drug Administration’s decision comes as GSK’s commercial head Luke Miels prepares to take over as CEO early next year, with the drugmaker facing U.S. tariffs and searching for new medicines to make up for older drugs losing patent protection.

On Monday, UK regulators also approved the drug, called Exdensur, and last week the European Medicines Agency recommended its approval. GSK has set a goal of reaching more than 40 billion pounds ($53.69 billion) in revenues by 2031, though analysts expect the new drug to help, even as they forecast sales closer to 34 billion pounds.

The FDA approved Exdensur as an add-on maintenance treatment for patients aged 12 years and older with severe asthma characterised by an eosinophilic phenotype. The drug is the first biologic cleared for twice-yearly dosing.

The drug, chemically known as depemokimab, is expected to compete with Sanofi and Regeneron’s Dupixent, Roche and Novartis’ Xolair, and Amgen and AstraZeneca’s Tezspire – all dosed every two to four weeks. GSK’s other respiratory drug Nucala targets the same protein as depemokimab.

The drugmaker was also seeking approval for the drug to treat chronic rhinosinusitis with nasal polyps.

GSK said the FDA declined to approve the drug for this indication. “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.