GlaxoSmithKline (GSK) has secured approval from the US Food and Drug Administration (USFDA) for two new methods for administering Nucala (mepolizumab), an auto-injector and a pre-filled safety syringe. Nucala is said to be the first anti-IL5 biologic to be licensed in the US for at-home administration, while the first respiratory biologic secured approval for administration through an auto-injector.
The approval will enable people with severe eosinophilic asthma (SEA) or the rare disease eosinophilic granulomatosis with polyangiitis (EGPA) to administer Nucala outside of a clinical setting by a patient or caregiver after their healthcare professional decides it is appropriate.
The original lyophilized powder version will continue to be available for administration by a healthcare professional. The approval was based on data from two open-label and single-arm, phase III studies, which assessed the real-world use of Nucala administered via the new options in-clinic and at home by patients with SEA or by their caregivers. Both studies demonstrate that patients have been able to successfully self-administer treatment with both the auto-injector and pre-filled syringe after appropriate training.
The majority of patients preferred at-home self-administration options compared against in-clinic administration. A further open-label, parallel-group and single-dose study affirmed that the pharmacokinetic and pharmacodynamic profile of Nucala, administered through pre-filled syringe or auto-injector, was comparable to the originally approved lyophilized formulation.