Asthma Patients in Europe Will Have Access to a Self-Administered Syringe

 

GlaxoSmithKline receives European marketing authorization for Nucala (mepolizumab) in a prefilled pen and safety syringe.

The European Commission has granted marketing authorization to GlaxoSmithKline (GSK) for its asthma treatment Nucala (mepolizumab) in two new administration forms –– a pre-filled pen and a pre-filled safety syringe. The approval is the first marketing authorization for self-administration by patients with severe eosinophilic asthma of a monthly anti-IL5 biologic in Europe.

Nucala was previously approved in Europe in 2015 as a lyophilized form, and this version will continue to be available — as a result, patients, their caregivers and healthcare professionals, will have three options to choose from. The monoclonal antibody targets IL-5 and is thought to inhibit the binding of IL-5 to its receptor on the surface of eosinophils, reducing blood eosinophils without completely depleting them.

The approval was based on positive results from two real-world open-label, single-arm, phase IIIa studies that demonstrated successful self-administration by patients of administration by caregivers using the pre-filled pen and pre-filled safety syringe after appropriate training.

 

 

David Alvaro, Ph.D.

David is Scientific Editorial Director for That’s Nice and the Pharma’s Almanac content enterprise, responsible for directing and generating industry, scientific and research-based content, including client-owned strategic content. Before joining That’s Nice, David served as a scientific editor for the multidisciplinary scientific journal Annals of the New York Academy of Sciences. He received a B.A. in Biology from New York University and a Ph.D. in Genetics and Development from Columbia University.