FDA OKs new administration options for GSK’s Nucala

GlaxoSmithKline’s Nucala (mepolizumab) has gained US Food and Drug Administration (FDA) approval for two new self-administration options, making the drug the first anti-IL5 biologic to give healthcare professionals the choice of how and where their patients receive treatment.

The company confirmed that the two new methods, autoinjector and a pre-filled safety syringe, are for patients or caregivers to administer once every four weeks, after a healthcare professional decides it is appropriate.

The approval will give healthcare professionals and people living with severe eosinophilic asthma (SEA) or the rare disease eosinophilic granulomatosis with polyangiitis (EGPA) the option and flexibility for Nucala to be administered outside of a clinical setting by a patient or caregiver, after their healthcare professional agrees this approach is appropriate.

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.

Tonya Winders, president of global allergy and asthma patient platform added: "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. 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."

Following this approval, it is expected that the new administration options for Nucala will be available in the US shortly.

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