GSK Files for Supplemental Biologics License to Expand the Use of Nucala in Pediatric Patients
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
Drug Solutions Podcast: Gliding Through the Ins and Outs of the Pharma Supply Chain
November 14th 2023In this episode of the Drug Solutions podcast, Jill Murphy, former editor, speaks with Bourji Mourad, partnership director at ThermoSafe, about the supply chain in the pharmaceutical industry, specifically related to packaging, pharma air freight, and the pressure on suppliers with post-COVID-19 changes on delivery.
