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.
