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European approval for two new delivery formulations of GSK's Nucala in severe eosinophilic asthma

Published on 02/08/19 at 10:13am

Following closely on the heels of the news that its deal to merge Pfizer’s consumer health business with its own, GSK has announced that Nucala (mepolizumab) had secured approval from the European Commission for two new delivery methods for patients with severe eosinophilic asthma to self-administer.

The drug, which is the only monthly anti-IL5 biologic approved in Europe, was authorised in a pre-filled pen and a pre-filled safety syringe form, based on Phase 3a data from two real-world studies which indicated that 98% of patients and 100% of caregivers were able to successfully administer the drug following adequate training, while 96% of patients preferred at-home administration rather than in-clinic.

Findings from an additional study also confirmed that the pharmacokinetic and pharmacodynamic profile of Nucala delivered via these two new methods was comparable to the originally approved lyophilised formulation.

“Making Nucala available for patients to take in the convenience of their own home is an important advance that builds on its proven efficacy, reflecting our ongoing efforts to meet the needs of patients with complex diseases,” commented Dr Hal Barron, Chief Scientific Officer and President, R&D, at GSK.

GSK confirmed that the European launch of the two new formulations is expected to proceed in August this year.

Matt Fellows

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