A novel therapy for COPD

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Emphysema and chronic bronchitis are the two most common conditions responsible for chronic obstructive pulmonary disease (COPD). Chronic bronchitis results from the inflammation of the lining of the bronchial tubes, which carry air to and from your lungs. Emphysema occurs when the air sacs (alveoli) at the end of the smallest air passages in the lungs are gradually and permanently destroyed.

COPD is irreversible, and about nine out of ten cases are caused by smoking. The CDC estimates that 4.7 million people in the U.S. have emphysema . Until now, the standard of care has been the same as for asthma inhalation of a mixture of a long-acting beta agonist (LABA) and an anti-inflammatory steroid (e.g. Advair).

But that may be about to change. Thanks to GlaxoSmithKline and Theravance, a new inhaled drug combination called Anoro Ellipta is likely to be approved, based on a 11-2 vote recommendation by an FDA expert advisory panel. The FDA usually follows the advice of the panel.

Anoro Ellipta is a combination of a long-acting beta-agonist (LABA) called vilanterol and umeclidinium, a long-acting muscarinic receptor antagonist (LAMA). Both of these drugs act (although by different mechanisms) by dilating the bronchial passages, causing smooth muscle cells to relax, which makes breathing easier.

According to Patrick Vallance, President of Pharmaceuticals R&D at Glaxo, "If approved, Anoro Ellipta will be the first, once-daily dual bronchodilator available in the US ¦.We will continue to work with the FDA as they complete their review."

ACSH s Dr. Josh Bloom is intrigued by this development. He says, It is not so easy to find a new therapy for a poorly-treatable disease. Whether Anoro Ellipta outperforms current therapies remains to be seen, but it has the advantage of not containing an anti-inflammatory steroid, which has its own set of baggage. Chronic use of steroids can lead to a host of side effects, including bone loss, ulcers, weight gain, elevated blood glucose and high blood pressure, although these effects are less common and less severe with a low-dose inhaled steroid rather than a high dose pill. Whether it will show an increased efficacy remains to be seen. And an obvious question is, will this work for asthma? Based on its mechanism of action, this is not unlikely. That would be a real game changer.