GSK's Exdensur Receives FDA Approval for Severe Asthma Treatment

On December 16, 2025, the U.S. Food and Drug Administration (FDA) approved GSK's Exdensur, also known as depemokimab, as an add-on maintenance treatment for severe eosinophilic asthma in patients aged 12 and older. This approval marks Exdensur as the first biologic treatment that requires administration only twice a year, offering a less frequent dosing option compared to existing therapies that typically require injections every two to four weeks. The approval follows earlier endorsements from the European Medicines Agency and the UK's health regulator.

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Exdensur has demonstrated significant efficacy in clinical trials, reducing serious asthma attacks by 54% and alleviating symptoms associated with chronic rhinosinusitis, such as nasal obstruction and polyp size. GSK's application to the FDA included data from at least four late-stage trials, with two trials indicating a reduction in asthma attacks and hospitalizations when Exdensur was added to standard treatment regimens.

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GSK anticipates that Exdensur could become a blockbuster drug, potentially generating annual sales of up to £3 billion ($4 billion). The company is positioning Exdensur as a key growth driver, especially as it faces challenges from U.S. tariffs and the impending expiration of patents on existing medications. GSK's commercial chief, Luke Miels, is set to take over as CEO early next year, emphasizing the importance of this drug in the company's future strategy.

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While the FDA approved Exdensur for severe asthma, it declined to approve the drug for chronic rhinosinusitis with nasal polyps, a decision that GSK is contesting. The company remains optimistic about the drug's potential benefits for this condition and is in ongoing discussions with the FDA. Additionally, GSK has submitted regulatory applications for Exdensur in China and Japan, indicating a broader strategy to expand its market reach.

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Despite the promising data, analysts caution that Exdensur's efficacy is comparable to existing treatments, which may impact its market uptake. The drug will compete with established therapies such as Sanofi and Regeneron's Dupixent, and Roche and Novartis' Xolair, all of which are administered more frequently. GSK's success with Exdensur will largely depend on patient acceptance of the new dosing regimen.

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A GSK spokesperson expressed confidence in Exdensur's potential, stating, "We remain confident in the benefit Exdensur could bring for patients with CRSwNP and are continuing discussions with the FDA." This sentiment underscores the company's commitment to addressing the needs of patients with severe asthma and related conditions.

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• “Exdensur is the first ultra-long acting biologic drug that needs to be administered just twice a year to treat these respiratory diseases.” — GSK Statement

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• “We remain confident in the benefit Exdensur could bring for patients with CRSwNP and are continuing discussions with the FDA,” — GSK Spokesperson

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In summary, GSK's Exdensur represents a significant advancement in the treatment of severe asthma, with its unique dosing schedule potentially reshaping patient management strategies in the coming years.

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