Regulatory Decision Summary for Nucala

The lyophilized drug product Nucala (mepolizumab for injection) for subcutaneous (SC) injection by healthcare professionals (HCPs) is currently authorized for severe eosinophilic asthma and eosinophilic granulomatosis with polyangiitis (EGPA) in Canada. This SNDS seeks the new mepolizumab liquid drug product (mepolizumab injection, 100 mg/mL solution) in a prefilled autoinjector and safety syringe for the same dose, dosing regimen, and route of administration (i.e., SC), as currently approved for the lyophilized drug product. The clinical data supporting the new liquid dosage forms of Nucala is primarily based on a comparative PK study that demonstrates bioequivalence between the proposed liquid product prefilled in either the autoinjector or safety syringe and the approved lyophilized product. In addition, the studies assessing actual use of the new liquid dosage forms in subjects with severe eosinophilic asthma showed almost all subjects (98%) can successfully administer a SC dose of 100 mg mepolizumab by self-injection in the thigh or abdomen, or in the upper arm by a caregiver (either in the clinic or at home). No new safety signals were identified and the adverse events reported in the studies are consistent with the currently known safety profile of mepolizumab.