User login
The Food and Drug Administration has approved umeclidinium as a once-daily, long-term treatment for airflow obstruction for patients with chronic obstructive pulmonary disease, GlaxoSmithKline announced April 30.
Incruse Ellipta (umeclidinium) is a long-acting muscarinic antagonist. It includes 62.5 mcg of umeclidinium delivered with the Ellipta inhaler.
Approximately 27 million people in the United States are affected by COPD, a lung disease that includes chronic bronchitis, emphysema, or both, according to the National Heart, Lung, and Blood Institute.
The phase III clinical trial for umeclidinium included seven clinical trials, which enrolled more than 2,500 COPD patients randomized to umeclidinium or placebo.
The most common adverse events with Incruse Ellipta (and placebo) were nasopharyngitis, 8% (7%); upper respiratory tract infection, 5% (4%); cough, 3% (2%); and arthralgia, 2% (1%). The drug is not recommended during rapidly deteriorating or potentially life-threatening COPD episodes, or as a rescue therapy for acute episodes of bronchospasm.
It is also recommended for the drug to be used with caution in patients with narrow-angle glaucoma and patients with urinary retention, especially prostatic hyperplasia or bladder neck obstruction.
Incruse Ellipta is currently approved in Canada and Europe, and is under review in several other countries. The firm says it plans to launch the drug in the United States in the fourth quarter of 2014.
The Food and Drug Administration has approved umeclidinium as a once-daily, long-term treatment for airflow obstruction for patients with chronic obstructive pulmonary disease, GlaxoSmithKline announced April 30.
Incruse Ellipta (umeclidinium) is a long-acting muscarinic antagonist. It includes 62.5 mcg of umeclidinium delivered with the Ellipta inhaler.
Approximately 27 million people in the United States are affected by COPD, a lung disease that includes chronic bronchitis, emphysema, or both, according to the National Heart, Lung, and Blood Institute.
The phase III clinical trial for umeclidinium included seven clinical trials, which enrolled more than 2,500 COPD patients randomized to umeclidinium or placebo.
The most common adverse events with Incruse Ellipta (and placebo) were nasopharyngitis, 8% (7%); upper respiratory tract infection, 5% (4%); cough, 3% (2%); and arthralgia, 2% (1%). The drug is not recommended during rapidly deteriorating or potentially life-threatening COPD episodes, or as a rescue therapy for acute episodes of bronchospasm.
It is also recommended for the drug to be used with caution in patients with narrow-angle glaucoma and patients with urinary retention, especially prostatic hyperplasia or bladder neck obstruction.
Incruse Ellipta is currently approved in Canada and Europe, and is under review in several other countries. The firm says it plans to launch the drug in the United States in the fourth quarter of 2014.
The Food and Drug Administration has approved umeclidinium as a once-daily, long-term treatment for airflow obstruction for patients with chronic obstructive pulmonary disease, GlaxoSmithKline announced April 30.
Incruse Ellipta (umeclidinium) is a long-acting muscarinic antagonist. It includes 62.5 mcg of umeclidinium delivered with the Ellipta inhaler.
Approximately 27 million people in the United States are affected by COPD, a lung disease that includes chronic bronchitis, emphysema, or both, according to the National Heart, Lung, and Blood Institute.
The phase III clinical trial for umeclidinium included seven clinical trials, which enrolled more than 2,500 COPD patients randomized to umeclidinium or placebo.
The most common adverse events with Incruse Ellipta (and placebo) were nasopharyngitis, 8% (7%); upper respiratory tract infection, 5% (4%); cough, 3% (2%); and arthralgia, 2% (1%). The drug is not recommended during rapidly deteriorating or potentially life-threatening COPD episodes, or as a rescue therapy for acute episodes of bronchospasm.
It is also recommended for the drug to be used with caution in patients with narrow-angle glaucoma and patients with urinary retention, especially prostatic hyperplasia or bladder neck obstruction.
Incruse Ellipta is currently approved in Canada and Europe, and is under review in several other countries. The firm says it plans to launch the drug in the United States in the fourth quarter of 2014.
