Nucala gains FDA approval for two new self-administration options

The US Food and Drug Administration yesterday approved marketing of autoinjector and prefilled safety syringe versions of GlaxoSmithKline's (LSE: GSK) asthma drug Nucala (mepolizumab), enabling self-administration of the monthly dose of the interleukin (IL)-5 inhibitor.

This is the first anti-interleukin (IL) 5 biologic to be licensed in the USA for at-home administration, and the first respiratory biologic to be approved for administration via an autoinjector, the company said.

This approval will give healthcare professionals and people living with severe eosinophilic asthma (SEA) or the rare disease eosinophilic granulomatosis with polyangiitis(EGPA) the option 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 original lyophilized powder version remains available for administration by a healthcare professional.