FDA to review GSK's depemokimab
By Iain Gilbert
Date: Monday 03 Mar 2025
(Sharecast News) - Pharmaceutical giant GSK said on Monday that the US Food and Drug Administration has agreed to review its Biologics License Application for the use of its depemokimab asset in two indications.
GSK said the proposed indications were as add-on maintenance treatment of asthma in adult and pediatric patients aged 12 years and older with type 2 inflammation characterised by an eosinophilic phenotype on medium- to high-dose inhaled corticosteroids plus another asthma controller and, as add-on maintenance treatment in adult patients with inadequately controlled chronic rhinosinusitis with nasal polyps.
The London-listed firm stated the submission of depemokimab for review was based on data from positive SWIFT and ANCHOR trials, which showed reduced exacerbation and hospitalisation rates, as well as early and sustained reductions in nasal polyp size and nasal obstruction versus placebo.
If approved, depemokimab will be the first ultra-long-acting biologic with a six-month dosing.
As of 0925 GMT, GSK shares were up 0.61% at 1,475.50p.
Reporting by Iain Gilbert at Sharecast.com
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