The US Food and Drug Administration (FDA) approved mepolizumab (Nucala, GlaxoSmithKline) for use in combination with other medications for maintenance treatment of severe asthma in patients aged 12 years or older and with an eosinophilic phenotype.
Mepolizumab is not approved for use in patients with other eosinophilic conditions or for emergency treatment of acute bronchospasm or status asthmaticus.
"This approval offers patients with severe asthma an additional therapy when current treatments cannot maintain adequate control of their asthma," Badrul Chowdhury, MD, PhD, director of the Division of Pulmonary, Allergy, and Rheumatology Products in the FDA's Center for Drug Evaluation and Research, said in an FDA news release.
"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," Professor Ian Pavord, University of Oxford, lead investigator of the first proof of concept trial for mepolizumab and an investigator for the Phase III Mepolizumab as Adjunctive Therapy in Patients with Severe Asthma (MENSA) study, said in a company news release. "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."
Mepolizumab is a humanized interleukin-5 antagonist monoclonal antibody that relieves severe asthma attacks by lowering levels of serum eosinophils. A healthcare professional administers 100 mg by subcutaneous injection into the upper arm, thigh, or abdomen once every 4 weeks. Patients continue to take their normal asthma medications while taking mepolizumab.
The FDA's Pulmonary-Allergy Drugs Advisory Committee recommended Nucala for approval in patients aged 18 years or older with severe asthma on June 11, 2015.
The panel voted 10 to 4 against recommending it for children aged 12 to 17 years because of lack of data in this population. Those votes followed a discussion of data from three double-blind, randomized, placebo-controlled trials.
The researchers conducted the safety and efficacy trials in patients with severe asthma who were taking currently available treatments. Patients received the study drug or placebo every 4 weeks as an add-on treatment for their asthma.
Patients with severe asthma who received mepolizumab experienced fewer exacerbations that necessitated hospitalization and/or emergency department care, and their time to first exacerbation was longer compared with patients who took placebo.
In addition, patients who received mepolizumab were able to reduce their daily oral corticosteroid dose while keeping their asthma under control compared with patients in the placebo group. However, patients in the mepolizumab group did not experience significant improvement in lung function on testing of the volume of air exhaled in 1 second (FEV1).
Adverse effects most commonly reported by patients taking mepolizumab include headache, injection-site reactions, back pain, and fatigue. Hypersensitivity reactions can occur in the first days and months after treatment with mepolizumab, and these include swelling of the face, mouth, and tongue, fainting, dizziness, lightheadedness, hives, breathing difficulty, and rash. Some patients taking mepolizumab have experienced herpes zoster, the virus that causes shingles.
"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," Eric Dube, senior vice president and head, GSK Global Respiratory Franchise, said in the company news release.
"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."
The Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency recommended approval of mepolizumab (Nucala, GlaxoSmithKline) for add-on maintenance treatment in adults with severe refractory eosinophilic asthma, on September 24, 2015.
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Cite this: FDA Approves Mepolizumab (Nucala) for Severe Asthma - Medscape - Nov 04, 2015.