The first respiratory biologic to be approved for administration via an autoinjector will be available in the US soon.
FDA cleared 2 new methods for administering mepolizumab (Nucala, GlaxoSmithKline): autoinjector and a pre-filled safety syringe. They are indicated
for patients or caregivers to administer once every 4 weeks.
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The approval gives 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, GlaxoSmithKline said in a statement.
The original lyophilised powder version remains available for administration by a healthcare professional.
“People living with conditions like severe asthma often struggle to control their day-to-day symptoms, making routine activities like attending healthcare appointments a challenge. 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 of the Global Allergy and Asthma Patient Platform (GAAPP), in the GlaxoSmithKline statement. “GAAPP welcomes this approval for Nucala so it can be administered in a doctor’s office or in the convenience of a patient’s home.”
The approval is supported by positive patient exaperience data from two open-label, single-arm, phase 3a studies 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% to 95% and 100% respectively). In addition, the majority of patients preferred at home self-administration options compared to in-clinic administration.
A separate open-label, parallel-group, single-dose study confirmed that the pharmacokinetic and pharmacodynamic profile of Nucala administered via pre-filled syringe or autoinjector was comparable to the originally approved lyophilised formulation, according to GlaxoSmithKline.