FDA approval of Utibron Neohaler is great news for COPD patients
Friday, November 06, 2015
Chronic obstructive pulmonary disease (COPD) is regarded as a progressive and life-threatening lung disease that can make it a challenging for an individual to breathe. The disease affects approximately 27 million Americans and is recognized as the third-leading cause of death in the United States.
To date there are a variety of respiratory agents for the management of COPD, and the recent FDA approval of Utibron Neohaler (indacaterol and glycopyrronium bromide) offers another option for individuals who are newly diagnosed or have this condition.
Utibron Neohalers provide a long-term maintenance treatment option, and are unique in the fact that they are a fixed combination of glycopyrronium bromide 15.6mg, a once-daily long-acting muscarinic antagonist, and indacaterol 27.5mg, a once-daily long-acting beta-2 agonist. This novel treatment approach appears to set it apart from other agents that are on the market, and Novartis expects Utibron Neohaler to be available in the first quarter of 2016.
The approval resulted from the performance of a phase II expedition trial program that recruited 2,654 patients with COPD for two 12-week efficacy studies and a one 52-week study. When compared to placebo, Utibron Neohaler demonstrated improvement in lung function at 12 weeks as well as improvement in health-related quality of life measures that include St. George's Respiratory Questionnaire.
Utibron Neohaler is an important approval as it offers a new dual-action bronchodilator option for patients and the potential for better quality of life through effective management of symptoms. It is important for healthcare providers and prescribers to be aware of the tremendous impact this approval can have for COPD management by targeting not only symptoms but also health-related quality of life for current and future patients.
While other COPD medications may only have one mechanism of action, Utibron is a combination drug with two approaches to target COPD. Historically, the treatments that have been used for COPD include long-acting bronchodilators to help reduce or prevent breathing problems and assist with the management of persistent symptoms.
Other medications that possess a single mechanism of action are the anticholingerics such as aclidinium, tiotropium or umeclidinium, which competitively and reversibly inhibit the action of acetylcholine at type 3 muscarinic receptors in bronchial smooth muscle, causing bronchodilation.
The two-mechanism approach of Utibron Neohaler seeks to blocks the action of acetylcholine at parasympathetic sites in smooth muscle, secretory glands and the CNS. This indirectly reduces the rate of salivation by preventing the stimulation of acetylcholine receptors and relaxes bronchial smooth muscle by selective action on beta2-receptors with little effect on heart rate.
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