GSK gets USFDA nod for new administration options for Nucala Biologic

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.