GSK asthma drug Nucala gets FDA approval
pharmafile | November 6, 2015 | News story | | GSK, Nucala, asthma, eosinophils, mepolizumab
GlaxoSmithKline has received approval from the FDA for Nucala as an add-on maintenance treatment of patients with severe asthma aged 12 years and older, who have an eosinophilic phenotype.
Nucala (mepolizumab) is now approved for patients who have a history of severe asthma attacks (exacerbations), despite receiving their current asthma medicines.
“This approval offers patients with severe asthma an additional therapy when current treatments cannot maintain adequate control of their asthma,” says Badrul Chowdhury, director of the division of pulmonary, allergy, and rheumatology products in the FDA’s Center for Drug Evaluation and Research.
Nucala is the first and only approved biologic therapy that targets interleukin-5 (IL-5), which plays an important role in regulating the function of eosinophils, an inflammatory cell known to be important in asthma. Studies suggest that approximately 60% of patients with severe asthma have eosinophilic airway inflammation.
Patients will receive Nucala in addition to their normal medications for severe asthma, which include high-dose inhaled corticosteroids plus at least one additional asthma control medicine, and in some cases oral corticosteroids.
Doctors generally try to avoid prescribing corticosteroids where possible, due to adverse side effects including osteoporosis and high blood pressure, and it is believed has the potential to reduce such prescriptions.
This is the first marketing authorisation granted for Nucala anywhere in the world. It follows three Phase III trials which established that, compared with placebo, patients with severe asthma receiving Nucala had fewer exacerbations requiring hospitalisation and/or emergency department visits, and a longer time to their first exacerbation.
Patients with severe asthma receiving Nucala also experienced greater reductions in their daily maintenance oral corticosteroid dose, while maintaining asthma control compared with patients receiving placebo.
Treatment with mepolizumab did not however result in a significant improvement in lung function, as measured by the volume of air exhaled by patients in one second.
Eric Dube, senior vice president and head of GSK’s global respiratory franchise says: “Following today’s approval, GSK can now offer, as part of our overall respiratory portfolio, a first-in-class biologic treatment for severe asthma patients whose condition is driven by eosinophilic inflammation.
“Our research has allowed us to better understand the specific role eosinophils play in severe asthma. We are proud of our contribution to this emerging area of science that has led to the approval of the first anti-IL5 treatment. We aim to offer this medicine to patients as soon as possible.”
Patients who were shown to benefit from treatment with Nucala in the Phase III clinical trials were those with blood eosinophil levels of 150 cells/mcL or greater just prior to treatment.
Professor Ian Pavord of University of Oxford, lead investigator of the first proof of concept trial and a Phase III study of mepolizumab, comments: “Severe asthma is a debilitating condition in which patients are at high risk of frequent and serious asthma attacks. Half of all severe asthma patients have at least one urgent care visit per year. As a clinician, the prospect of a treatment that can specifically target the underlying cause of the disease for patients whose condition is driven by eosinophilic inflammation is exciting.”
Joel Levy
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