GSK secures US FDA approval for "innovative" severe asthma treatment

 GSK PLC on Wednesday said its Exdensur treatment, depemokimab, for severe asthma has been approved by the US Food & Drug Administration.

The regulatory approval is based upon phase three Swift trials, noted GSK, which demonstrated a "significantly lower" rate of annualised asthma exacerbations with patients receiving depemokimab versus placebo.

The London-based pharmaceuticals firm explained the approval for Exdensur is as an add-on maintenance treatment of severe asthma "characterised by an eosinophilic phenotype" in both adult and paediatric patients aged 12 and above.

GSK added that the treatment is the first and only "ultra-long-acting biologic" that has twice yearly dosing approved for patients suffering from severe asthma with an eosinophilic phenotype.

On Monday, GSK reported that Exdensur had gained marketing approval in the UK for the treatment of asthma with type 2 inflammation and chronic rhinosinusitis with nasal polyps.

https://global.morningstar.com/en-gb/news/alliance-news/1765965057044339800/gsk-secures-us-fda-approval-for-innovative-severe-asthma-treatment