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GSK’s Exdensur Gains US FDA Approval for Severe Asthma Treatment

GlaxoSmithKline announced that the US Food and Drug Administration has approved its twice-annual asthma therapy Exdensur, offering a new option for patients aged 12 and older with severe eosinophilic asthma inadequately controlled by standard treatment.

Exdensur, known by its active ingredient depemokimab, is designed as an add-on maintenance treatment that can be administered just twice a year, potentially improving convenience and adherence for patients living with persistent symptoms. The decision follows positive clinical evidence showing significant reductions in asthma exacerbations and hospital visits when added to existing therapies, underscoring its potential impact on this patient population.

GSK expects Exdensur to complement current biologics and become an important part of its respiratory portfolio. The FDA’s approval comes alongside recent regulatory milestones in other regions, reinforcing the drug’s global rollout for severe asthma care.

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GSK’s Exdensur Gains US FDA Approval for Severe Asthma Treatment

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