GlaxoSmithKline (GSK) has secured marketing authorisation from the European Commission (EC) for two new administration options of Nucala (mepolizumab) to treat patients with severe eosinophilic asthma.
Nucala, a pre-filled pen and a pre-filled safety syringe, is claimed to be the only monthly anti-IL5 biologic approved in Europe to treat patients with severe eosinophilic asthma at home.
Mepolizumab, which was first approved in 2015 for severe eosinophilic asthma, is the first-in-class monoclonal antibody that targets IL-5.
It is believed to work by inhibiting IL-5 from binding to its receptor on the surface of eosinophils, helping to reduce blood eosinophils without completely depleting them.
The company will provide Nucala with new administering methods from this month to the patients. It also continues to provide the original lyophilised version, allowing healthcare professionals to select different administration options as per the requirement.
The approval was based on data from two real-world, open-label and single-arm and phase 3a studies, including NCT03099096 and NCT03021304.
According to the company, the patients and caregivers were able to successfully self-administer Nucala with the pre-filled pen and pre-filled safety syringe after appropriate training by the conclusion of the studies.
A further open-label, parallel-group and single-dose study also showed that the pharmacokinetic and pharmacodynamic profile of Nucala administered via the pre-filled safety syringe or pre-filled pen was similar to the originally approved lyophilised formulation.
Developed to treat diseases that are driven by inflammation caused by eosinophils, the mepolizumab has been assessed in more than 3,000 patients in 21 clinical trials across a number of eosinophilic indications.
In addition, mepolizumab is the only anti-IL-5 biologic approved for paediatric use from ages six to 17 to treat severe eosinophilic asthma in Europe. It is currently being evaluated investigated for the severe hypereosinophilic syndrome, nasal polyposis and COPD.
GSK chief scientific officer and president Dr Hal Barron said: “Making Nucala 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.”
In July this year, GSK said that a phase 3 trial evaluating its polymerase (PARP) inhibitor Zejula (niraparib) as maintenance therapy for first-line ovarian cancer following platinum-based chemotherapy, has met its primary endpoint.