7 June 2019 - GlaxoSmithKline’s Nucala (mepolizumab) has gained US FDA approval for two new self-administration options, making the drug the first anti-IL5 biologic to give healthcare professionals the choice of how and where their patients receive treatment.

The company confirmed that the two new methods, autoinjector and a pre-filled safety syringe, are for patients or caregivers to administer once every four weeks, after a healthcare professional decides it is appropriate.

The approval will give healthcare professionals and people living with severe eosinophilic asthma or the rare disease eosinophilic granulomatosis with polyangiitis the option and flexibility 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 approval is supported by positive patient experience data from two open-label, single-arm, phase IIIa studies (NCT03099096 & NCT03021304) evaluating the real-world use of Nucala administered via the new options in-clinic and at home by patients with SEA, or by their caregivers.

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