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.
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.
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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