GlaxoSmithKline, a leading research-based pharmaceutical and healthcare company, recently announced that the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) has recommended marketing authorization for mepolizumab, a monoclonal antibody that stops IL-5 from binding to its receptor on the surface of eosinophils, reducing blood, tissue and sputum eosinophil levels.
The drug will be commercialized as Nucala, and works as an add-on therapy for adult patients with severe refractory eosinophilic asthma.
This positive opinion was based on the data retrieved from a clinical trial program in which patients were identified as suitable for being treated with mepolizumab.
Patients with a diagnosis of severe refractory eosinophilic asthma took part in the Phase III clinical trials and were examined through eosinophil levels and a clinical history of recurrent exacerbations or a dependency on systemic corticosteroids. All study participants were being treated with high-dose inhaled corticosteroids and other maintenance therapy.
Dave Allen, Head, Respiratory Therapy Area Unit, R&D, said, “For these difficult-to-treat patients there are very limited treatment options. Many struggle to control their asthma even when taking high doses of inhaled therapies and are often reliant on daily oral corticosteroids, which can cause serious long-term side effects. This positive opinion brings us a step closer to adding a targeted biologic therapy, specifically developed for patients with severe eosinophilic asthma, to our respiratory portfolio.”
Mepolizumab is delivered every four weeks via subcutaneous injection in a 100mg dose. The phase III trials assessed the safety and efficacy of mepolizumab in a population of 915 patients with a diagnosis of severe asthma that received mepolizumab as an add-on to standard treatment.
All participants in the MEA115588 and MEA115575 clinical trials had peripheral blood eosinophil levels equal of superior to 150 cells/μL at treatment initiation or equal or superior to 300 cells/μL within the past year.
In November 2014, the company submitted the Marketing Authorisation Application for mepolizumab to the EMA. The CHMP positive feedback is an official recommendation that grants marketing approval for mepolizumab. If the drug gets the final approval, it would be the first anti-IL5 biological therapy ever approved for the treatment of this severe condition.
It is anticipated that the European Commission will provide its opinion before the end of this year.
Asthma is a heterogeneous disease in which adequate asthma control cannot be achieved in a substantial proportion despite currently available treatment possibilities. This subgroup has been defined as “severe refractory” asthma. Over the past years considerable progress has been made regarding a more exact definition of severe refractory asthma.