The US Food and Drug Administration (FDA) today approved umeclidinium and vilanterol powder for inhalation (Anoro Ellipta, GlaxoSmithKline (GSK)/Theravance). The drug is the first combo bronchodilator treatment indicated "for once-daily, long-term maintenance treatment of airflow obstruction in patients with chronic obstructive pulmonary disease (COPD)," according to an FDA statement.
"GSK conducted a clinical program that included dose-ranging trials of varying duration for the individual components, two 6-month, placebo-controlled efficacy and safety trials, two 6-month, active-controlled efficacy and safety trials, and a 12-month safety trial," according to an FDA briefing from a September 10 meeting of the FDA's Pulmonary Drugs Advisory Committee
In all, the safety and efficacy of umeclidinium and vilanterol powder for inhalation were evaluated in over 2400 patients with a diagnosis of COPD. Those treated showed improved lung function compared with placebo recipients, according to the FDA.
At the advisory committee meeting, the committee recommended the drug after voting unanimously that umeclidinium and vilanterol 62.5/25 μg had a clinically significant benefit for patients with moderate to severe COPD, including chronic bronchitis and emphysema.
The committee voted 10 to 3 in favor of the drug's safety because the incidence of adverse cardiovascular events that occurred in clinical studies was fairly low but still concerning to committee members.
The committee had discussed whether to recommend labeling that includes a warning on the use of umeclidinium/vilanterol in patients with cardiovascular disease and recommended postmarketing studies to better assess safety of the drug combination.
A New "Convenient" Option
The medication is based very much on the Global Initiative for Chronic Lung Disease (GOLD) guidelines, which are guidelines that have been around for years and were revised within the last year or so, Norman H. Edelman, MD, senior medical advisor, American Lung Association, told Medscape Medical News. Dr. Edelman said he has had no personal experience with the drug combination, but he does see an upside.
"[The guidelines] recommend, as a starting medication, other than the quick reliever for sudden shortness of breath, a long-acting bronchodilator. There are 2 classes of long-acting bronchodilator. One is a so-called anticholinergic, and the other is a beta-2 agonist," Dr. Edelman explained. "Not infrequently, physicians will try those serially — start one, and if it doesn't work, add the other. This takes those 2 classes of drugs — they're new drugs, but they belong to those 2 classes — and combines them into a single inhaler.
"For physicians who...want to prescribe both classes of long-acting bronchodilators, this will allow them to do that with 1 prescription, and be much more convenient for their patients," Dr. Edelman said.
Serious adverse effects include paradoxical bronchospasm, cardiovascular effects, acute narrow-angle glaucoma, and worsening of urinary retention. The most frequent adverse effects reported by patients using the drug included pharyngitis, sinusitis, lower respiratory tract infection, constipation, diarrhea, extremity pain, muscle spasms, neck pain, and chest pain, according to the FDA.
The drug will carry a boxed warning stating that long-acting beta-agonists raise the risk for asthma-related death. The safety and efficacy of the umeclidinium/vilanterol combination have not been established in patients with asthma, and the combination is not approved for asthma treatment. It also is not intended to be used as a rescue therapy for sudden breathing problems, including bronchospasm, the FDA statement notes.
GSK says in a news release it anticipates that launch activities in the United States will commence during the first quarter of 2014.
Dr. Edelman has disclosed no relevant financial relationships.
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Cite this: FDA Approves Umeclidinium and Vilanterol Combo for COPD - Medscape - Dec 18, 2013.