FDA OKs Two Self-Administered Options for Mepolizumab (Nucala)

Megan Brooks


June 06, 2019

The US Food and Drug Administration (FDA) has approved two new methods for administering mepolizumab (Nucala, GlaxoSmithKline), an autoinjector and a prefilled safety syringe, which patients or caregivers can administer at home once every 4 weeks, the company announced.

Mepolizumab is the first anti-interleukin-5 biologic to be licensed in the United States for at-home administration, and the first respiratory biologic to be approved for administration via an autoinjector, GlaxoSmithKline said in a news release.

The company notes that the approval of mepolizumab for at-home use is supported by positive patient experience data from two open-label, single-arm, phase 3a studies evaluating the real-world use of the drug administered via the new options in clinic and at home by patients with severe eosinophilic asthma or their caregivers.

"Both studies showed patients were able to successfully self-administer treatment with both the autoinjector and prefilled 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," the company said.

A further open-label, parallel-group, single-dose study confirmed that the pharmacokinetic and pharmacodynamic profile of mepolizumab administered via prefilled syringe or autoinjector was comparable to the originally approved lyophilized formulation.

The company said mepolizumab autoinjector and prefilled safety syringe will be available in the United States shortly.

"Nucala's efficacy is well-established and this approval means that, for the first time, we are able to provide patients living with these debilitating conditions the option of receiving this important medicine in their own home," Hal Barron, MD, chief scientific officer at GlaxoSmithKline, said in the release.

Tonya Winders, president, Global Allergy and Asthma Patient Platform (GAAPP), 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."

Mepolizumab subcutaneous injection was first approved in the United States in 2015 as an add-on maintenance treatment for patients with severe asthma aged 12 years and older and with an eosinophilic phenotype.

The FDA expanded the indication in 2017 for treatment of adults with eosinophilic granulomatosis with polyangiitis (EGPA). Mepolizumab is not intended for the relief of acute bronchospasm or status asthmaticus.

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