The Food and Drug Administration has approved two new self-administration options for Nucala (mepolizumab; GlaxoSmithKline), making it the first interleukin-5 antagonist biologic agent for at-home administration. Previously, the treatment had only been available as a lyophilized powder for reconstitution that required administration by a healthcare professional.  

The approval was based on data from 2 open label single arm phase 3a studies in which Nucala self-administration was evaluated in patients with severe eosinophilic asthma. Results showed that after proper training, patients were able to successfully administer the drug both via the autoinjector (89-95%) and prefilled safety syringe (100%). Moreover, the pharmacokinetics of Nucala administered through these 2 methods was found to be comparable to that of the lyophilized formulation based on data from an open label, parallel group, single-dose study.

Nucala is indicated for the add-on maintenance treatment of patients with severe asthma ≥12 years old, and with an eosinophilic phenotype. It is also approved for the treatment of adult patients with eosinophilic granulomatosis with polyangiitis.

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Nucala is intended for use under the guidance of a healthcare provider. A patient may self-inject or the patient caregiver may administer the treatment after the clinician determines it is appropriate and the patient has received proper training on subcutaneous injection.

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The autoinjector and prefilled safety syringe are expected to be available soon, both in a 100mg/mL dosage strength; the lyophilized powder formulation containing 100mg of mepolizumab per vial will continue to be supplied as well.

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This article originally appeared on MPR