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GSK: Nucala Gets FDA Approval For Two New Self-administration Options

GlaxoSmithKline plc (GSK.L,GSK) announced Friday that the US Food and Drug Administration has approved two new methods for administering Nucala (mepolizumab), an autoinjector and a pre-filled safety syringe.

The approval allows patients or caregivers to administer it once every four weeks, after a healthcare professional decides it is appropriate. The new administration options for Nucala will be available in the US shortly.

Healthcare professionals and people living with severe eosinophilic asthma or SEA, or the rare disease eosinophilic granulomatosis with polyangiitis or EGPA will now have the option for Nucala to be administered outside of a clinical setting.

The approval is supported by positive patient experience data from two open-label, single-arm, phase IIIa studies. These evaluated the real-world use of Nucala administered via the new options in-clinic and at home by patients with SEA, or by their caregivers.

The company said the original lyophilised powder version remains available for administration by a healthcare professional.

GSK said this is the first anti-IL5 biologic to be licensed in the US for at-home administration. It is also the first respiratory biologic to be approved for administration via an autoinjector.

Nucala was first approved in 2015 for severe eosinophilic asthma.

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