Posted by Michael Wonder on 02 Aug 2019
Nucala receives EU approval for self-administration by patients with severe eosinophilic asthma
1 August 2019 - 96% of patients in studies preferred self-administration at home over being treated in clinic.
GlaxoSmithKline today announced that the European Commission has granted marketing authorisation for two new methods of administering Nucala (mepolizumab): a pre-filled pen and a pre-filled safety syringe. This is the only monthly* anti-IL5 biologic approved in Europe that people with severe eosinophilic asthma can take at home, after a healthcare professional decides it is appropriate.
The marketing authorisation is supported by positive experience data from two real-world open-label, single-arm, phase 3a studies (NCT03099096 & NCT03021304). By the conclusion of the studies, patients and caregivers were able to successfully self-administer Nucala with the pre-filled pen and pre-filled safety syringe after appropriate training (98% and 100% respectively). 96% of patients preferred the at-home administration options compared to in-clinic administration.
