GSK gets European nod for pre-filled pen, syringe Nucala for patients with severe eosinophilic asthma

UK: GlaxoSmithKline (GSK) recently announced that the European Commission has granted marketing authorization for two new methods of administering Nucala (mepolizumab), a pre-filled pen and a pre-filled safety syringe.

The product 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.

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

Commenting on the same, 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.

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The marketing authorization is supported by positive experience data from two real-world open-label, single-arm, phase 3a studies (NCT03099096 & NCT03021304). By the conclusion of the studies, patients and caregivers were able to successfully self-administer Nucala with the pre-filled pen and pre-filled safety syringe after appropriate training (98% and 100% respectively). 96% of patients preferred the at-home administration options compared to in-clinic administration.

A further open-label, parallel-group, single-dose study (NCT03014674), confirmed that the pharmacokinetic and pharmacodynamic profile of Nucala administered via the pre-filled safety syringe or prefilled pen was comparable to the originally approved lyophilized formulation.

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