The US FDA has approved two new methods for administering Nucala (mepolizumab), including an autoinjector and a pre-filled safety syringe that can be self-administered by patients or caregivers once every four weeks.
According to GlaxoSmithKline, this is the first anti-IL5 biologic to be licensed in the US for at-home administration, and the first respiratory biologic to be approved for administration via an autoinjector.
“This approval will give healthcare professionals and people living with severe eosinophilic asthma (SEA) or the rare disease eosinophilic granulomatosis with polyangiitis (EGPA) the option for Nucala to be administered outside of a clinical setting by a patient or caregiver after their healthcare professional agrees this approach is appropriate,” GSK said in a press release.
The original lyophilised powder version remains available for administration by a healthcare professional.
“Empowering patients to take their medicines at home is an approach that has been successful in other chronic diseases such as diabetes and rheumatoid arthritis,” said Tonya Winders, President, Global Allergy and Asthma Patient Platform (GAAPP).
The approval is supported by positive patient experience data from two open-label, single-arm, phase IIIa studies (NCT03099096 & NCT03021304) evaluating 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 showed patients were able to successfully self-administer treatment with both the autoinjector and pre-filled syringe after appropriate training (89-95% and 100% respectively). In addition, the majority of patients preferred at home self-administration options compared to in-clinic administration.
A further open-label, parallel-group, single-dose study (NCT03014674) confirmed that the pharmacokinetic and pharmacodynamic profile of Nucala administered via pre-filled syringe or autoinjector was comparable to the originally approved lyophilised formulation.
Following this approval, it is expected that the new administration options for Nucala will be available in the US shortly.