GlaxoSmithKline has announced that the European Medicines Agency’s (EMA) Committee for Medicinal Products for Human Use (CHMP) has issued a positive opinion recommending two new methods for administering Nucala (mepolizumab) to patients with severe eosinophilic asthma: a pre-filled pen and a pre-filled safety syringe, to be taken once every four weeks.
If approved, the two new Nucala options will offer healthcare professionals the choice of prescribing at-home administration for appropriate patients. The original lyophilised powder version remains available for administration in clinic by a healthcare professional.
A CHMP positive opinion is one of the final steps before marketing authorisation is granted by the European Commission.
The CHMP opinion is supported by positive experience data from two open-label, single-arm, phase IIIa studies (NCT03099096 & NCT03021304) evaluating the real-world use of Nucala (mepolizumab) administered via the new options in clinic and at home by patients with severe eosinophilic asthma, or their caregivers. Both studies showed patients were able to successfully self-administer treatment with both the pre-filled pen and pre-filled safety syringe after appropriate training (89-95% and 100% respectively). In addition, the majority of patients preferred at-home administration options compared to in-clinic administration.
A further open-label, parallel-group, single-dose pharmacokinetic and pharmacodynamic study (NCT03014674), confirmed that the profile of Nucala administered via the pre-filled safety syringe or pre-filled pen was comparable to the originally approved lyophilised formulation.
First approved in 2015 for severe eosinophilic asthma, mepolizumab is the first-in-class monoclonal antibody that targets IL-5. It is believed to work by preventing IL-5 from binding to its receptor on the surface of eosinophils. Inhibiting IL-5 binding in this way reduces blood eosinophils.
Mepolizumab has been developed for the treatment of diseases that are driven by inflammation caused by eosinophils. It has been studied in over 3,000 patients in 16 clinical trials across a number of eosinophilic indications and has been approved (under the brand name Nucala) in the US, Europe and in over 20 other markets, as an add-on maintenance treatment for patients with severe eosinophilic asthma. It is also the only anti IL-5 biologic therapy approved for paediatric use from ages six to 17 in Europe in severe eosinophilic asthma. In the US, Japan, Canada and a number of other markets, it is also approved as add-on maintenance treatment for patients with eosinophilic granulomatosis with polyangiitis (EGPA). Mepolizumab is currently being investigated for severe hypereosinophilic syndrome, nasal polyposis and COPD.
In Europe, Nucala is indicated as an add-on treatment for severe refractory eosinophilic asthma in adults, adolescents and children aged 6 years and older.
Nucala 100mg solution for injection in pre-filled pen and pre-filled syringe are only appropriate for use by adults and adolescents aged 12 years and over and are not indicated for administration to children aged 6 to 11 years old. This population should be treated with the lyophilised powder for solution for injection.