The Food and Drug Administration on Dec. 18 approved Anoro Ellipta (umeclidinium 62.5 mcg/vilanterol 25 mcg), an anticholinergic/beta2-agonist, once-daily combination inhaler for long-term maintenance treatment of airflow obstruction in chronic obstructive pulmonary disease.
Manufacturer GlaxoSmithKline plans to launch the product during the first quarter of 2014, the company said in a statement.
FDA’s review panel unanimously agreed that the inhaler provided clinically meaningful benefits, based on Glaxo’s clinical trials, but panelists were concerned about its safety in patients with severe heart disease. There were numerical imbalances in ischemia-related events in primary efficacy trials that were not seen in a long-term safety study. Generalizability of the cardiac safety data was also a concern because trial exclusion criteria may have eliminated patients with more severe heart disease.
Glaxo noted in its statement that the drug "should be used with caution in patients with cardiovascular disorders, especially coronary insufficiency, cardiac arrhythmias, and hypertension. ... Beta2-agonists, such as vilanterol, should be administered with extreme caution to patients being treated with drugs known to prolong the QTc interval or within 2 weeks of discontinuation of such agents."
Caution also was advised when Anoro Ellipta is considered for coadministration "with long-term ketoconazole and other known strong cytochrome P450 3A4 inhibitors because increased cardiovascular adverse effects may occur," the company said.
The FDA also noted cardiovascular effects among "serious side effects," as well as paradoxical bronchospasm, narrow-angle glaucoma, and worsening of urinary retention.
More common side effects include pharyngitis, sinusitis, lower respiratory tract infection, constipation, diarrhea, extremity pain, muscle spasms, neck pain, and chest pain.
The product will come with a patient medication guide and carry a boxed warning that long-acting beta2-adrenergic agonists like vilanterol increase the risk of asthma-related death. Umeclidinium, the other drug in the combination inhaler, is an anticholinergic.
"Anoro Ellipta should not be initiated in patients during rapidly deteriorating or potentially life-threatening episodes of COPD, or as rescue therapy for the treatment of acute episodes of bronchospasm, which should be treated with an inhaled, short-acting beta2-agonist," Glaxo noted.
Frontline Medical News reporter Elizabeth Mechcatie contributed to this report.