First-in-class biologic maintenance therapy approved for severe asthma

November 18, 2015

FDA approved mepolizumab (Nucala) as an add-on maintenance therapy for the treatment of patients with severe asthma who are 12 years and older and with an eosinophilic phenotype.

FDA approved mepolizumab (Nucala) as an add-on maintenance therapy for the treatment of patients with severe asthma who are 12 years and older and with an eosinophilic phenotype.

MTM essentials for asthma management: Part 1

The biologic is approved for patients who have a history of severe asthma attacks despite the use of current asthma therapies. It has been demonstrated to reduce the frequency of severe asthma attacks, according to FDA.

MTM essentials for asthma management: Part 2

Nucala, developed by GlaxoSmithKline, is an interleukin-5 (IL-5) antagonist monoclonal antibody that reduces the production and survival of esosinophils, which are one of the inflammatory cell types involved in asthma. The biologic is to be administered once every four weeks by a healthcare professional at a recommended dose of 100 mg by subcutaneous injection.

“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,” said Eric Dube, senior vice president and head of GSK Global Respiratory Franchise. “We aim to offer this medicine to patients as soon as possible.”

Clinical trials

Three double-blind, randomized, placebo-controlled trials were undertaken to evaluate the safety and efficacy of mepolizumab, including a dose-ranging and exacerbation trial and two confirmatory trials. The biologic was administered every 4 weeks as add-on therapy to current asthma treatment, according to the manufacturer’s package insert.

The primary endpoint for two of the trials was the frequency of exacerbations, which included the need for use of oral/systemic corticosteroids and/or hospitalization and/or emergency department visits.

“Compared with placebo, subjects receiving Nucala [mepolizumab at 100 mg subcutaneously] or mepolizumab 75 mg IV experienced significantly fewer exacerbations,” according to the package insert.

 

“Additionally, compared with placebo, there were fewer exacerbations requiring hospitalization and/or emergency department visits and exacerbations requiring only in-patient hospitalization with Nucala,” the labeling information stated.

Patients with severe asthma who received Nucala had greater reductions in their daily maintenance oral corticosteroid use than the placebo-treated patient group. However, Nucala did not significantly improve lung function, according to FDA .

Common side effects associated with Nucala included headache, injection-site reactions, back pain, and fatigue. Patients should be aware of possible hypersensitivity reactions within the first hours or days of treatment, and if these reactions occur, the drug should be discontinued.

In the clinical trials, there were two serious cases of herpes zoster in patients treated with Nucala. Patients should receive a varicella vaccination prior to initiation of the biologic. In addition, patients with a pre-existing helminth infection should be treated for that infection before starting Nucala.

Nucala should not be used for the treatment of acute bronchospasm or status asthmaticus.