GSK Files for Supplemental Biologics License to Expand the Use of Nucala in Pediatric Patients

November 20, 2018

GSK has filed for a sBLA to FDA for the expansion of the indication of Nucala to include paediatric patients between 6 and 11 years old.

GlaxoSmithKline has filed for a supplemental Biologics License Application (sBLA) to FDA in order to expand the indication of Nucala (mepolizumab) to include pediatric patients aged between 6 and 11 years old who suffer with severe eosinophilic asthma within the United States.

Mepolizumab is a humanized anti-IL5 monoclonal antibody that originally received FDA-approval in 2015 for use in the treatment of severe eosinophilic asthma in patients aged 12 years and older. The latest submission as an add-on treatment for younger patients is supported by an open-label study that investigated pharmacokinetics, pharmacodynamics, and long-term safety.

The treatment has already been granted a license in Europe for pediatric patients aged between 6 and 17 years. Currently, there are no targeted biologic therapies available in the US for patients suffering with severe eosinophilic asthma who are as young as six years old.

Source: GSK