GlaxoSmithKline (GSK) announced in a press release that Nucala® (mepolizumab) has been granted marketing authorization as an add-on treatment by the European Commission. After receiving Food and Drug Administration (FDA) approval in the United States and a Committee for Medicinal Products for Human Use (CHMP) recommendation in the Europe earlier this year, Nucala will now be available in 31 European countries that the European Medicines Agency (EMA) covers as the first approved biologic therapy targeting interleukerin-5 (IL-5) treatment for patients with severe refractory eosinophilic asthma in adult patients.
Interleukin-5 (IL-5) plays a crucial role in regulating eosinophils, an inflammatory cell known to play an important role in asthma. Nucala is a monoclonal antibody that stops IL-5 from connecting to its receptor on the surface of eosinophils. By inhibiting IL-5 from binding in this way, the treatment reduces blood, tissue and sputum eosinophil levels. Nucala is administered as a 100mg subcutaneous injection every four weeks, in addition to the patient’s normal medication.
“The marketing authorization of Nucala in the EU is a significant treatment advance for appropriate asthma patients and reinforces GSK’s leadership in respiratory. We are proud that our work in this area, to better understand the specific role eosinophils play in severe asthma, has resulted in the licensing of mepolizumab as the first anti-IL-5 biological treatment. We aim to offer this medicine to patients as soon as possible,” explained Eric Dube, who is the Senior Vice President & Head of GSK Global Respiratory Franchise.
The head researcher of the inaugural proof of concept trial for mepolizumab, also involved in the Phase III MENSA study, Professor Ian Pavord from Oxford University, commented: “Patients with severe refractory eosinophilic asthma are not the typical ‘asthma’ patients many people are familiar with. Despite taking high doses of inhaled medications, they struggle to control their asthma. They have particular problems with frequent asthma attacks and can require hospitalization. Many also take oral corticosteroids to control their symptoms, which we know can lead to side effects that patients often find very difficult to deal with. To be able to offer these patients a treatment that specifically targets the underlying cause of their disease will be an important option.”
The Phase IIb/III clinical development program for mepolizumab studied the efficacy and safety of the drug in patients with severe asthma. The results showed that all patients involved in the trials MEA115588 (MENSA) and MEA115575 (SIRIUS) had peripheral blood eosinophil levels greater than or equal to 150 cells/μL at initiation of treatment or greater than or equal to 300 cells/μL in the 12 months prior to the clinical investigation.
If you would like to learn more about Nucala, you can read the EU Summary of Product Characteristics for Nucala. If you are a U.S. Citizen and would like to know more about Prescribing Information, please read the US Prescribing Information Nucala.