GlaxoSmithKline has announced that the European Commission has granted marketing authorisation for two new methods of administering the company’s Nucala (mepolizumab) - a pre-filled pen and a pre-filled safety syringe.
It 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 first European launches of the new administration options are expected to take place in August 2019, but the original lyophilised version remains available, giving healthcare professionals a choice of three different administration options to best fit in with their patients’ lives.
The marketing authorisation is supported by positive experience data from two real-world open-label, single-arm, phase IIIa studies (NCT03099096 & NCT03021304) that found 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).
Dr Hal Barron, chief scientific officer and president, R&D, GSK, said that making the drug available for patients to take in the convenience of their own home is an "important advance that builds on its proven efficacy, reflecting our ongoing efforts to meet the needs of patients with complex diseases.”
First approved in 2015 for severe eosinophilic asthma, Nucala is the first-in-class monoclonal antibody that targets IL-5. It is believed to work by preventing IL-5 from binding to its receptor on the surface of eosinophils, reducing blood eosinophils without completely depleting them.