Tuesday, 28 June 2022

Nucala by GSK receives EU approval for patients with severe eosinophilic asthma

02 August 2019 | News

96% of patients in studies preferred self-administration at home over being treated in clinic

GlaxoSmithKline has announced that the European Commission has granted marketing authorisation for two new methods of administering Nucala (mepolizumab): a pre-filled pen and a pre-filled safety syringe. This is the only monthly anti-IL5 biologic approved in Europe that people with severe eosinophilic asthma can take at home, after a healthcare professional decides it is appropriate.

Dr Hal Barron, Chief Scientific Officer and President, R&D, GSK, said: “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.”

Severe eosinophilic asthma can have a life-changing impact, with patients experiencing asthma symptoms that remain uncontrolled despite high-dose standard treatments. This can leave them struggling to breathe and at increased risk of a potentially fatal asthma attack.

The first European launches of the new administration options are expected to take place in August 2019. The original lyophilised version remains available, giving healthcare professionals a choice of three different administration options to best fit in with their patients’ lives.


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