By Eve Green
Partner companies Theravance and the GlaxoSmithKline have received Food and Drug Administration clearance for their new drug for the treatment of COPD, Breo Ellipta. COPD encompasses what used to be known as emphysema and chronic bronchitis – the new drug should be an improvement on current treatment options which can ease the symptoms of this disease. COPD, which is strongly linked to smoking, is the third most significant cause of death in America.
Curtis Rosebraugh, director of FDA Office of Drug Evaluation II, commented that this new long-term maintenance treatment for COPD will provide new care options for the millions of people in the USA who suffer from the condition. The companies have stated that the drug should be available during the third quarter of 2013. Breo Ellipta, which requires a single dose per day, should surpass existing treatments which require two doses.
COPD
COPD stands for chronic obstructive pulmonary disease, a progressive condition (one which continually worsens) which causes breathing problems in those who suffer from it. The symptoms are coughing and the associated overproduction of mucus, shortness of breath especially during exercise and tightness of chest. COPD is also associated with a greater susceptibility to chest-infections. Doctors used to refer to ’emphysema’ and ‘chronic bronchitis’, though these are now officially grouped under this general condition.
A disease which is currently under-diagnosed, this condition refers to the inflammation and subsequent damage to the interior of the lungs, and results in lower efficiency in taking on oxygen and in problems with the mechanics of breathing. Smoking is the top cause of COPD, though a genetic predisposition can cause it in some people. While the damage which it causes cannot be repaired, sufferers who subsequently quit smoking can slow down the progress of the disease.
The Drug
Breo Ellipta is based on two forms of medication which are known to suppress the symptoms of COPD. These are fluticasone furoate, an corticosteroid, and vilanterol, a beta2-adrenergic agonist. Both of these compounds are administered to the affected area through an inhaler similar to those which are used to treat asthma.
Corticosteroids are a sub-category of the steroid class of chemicals (which includes hormones). Known as ‘anti-inflammatory’ drugs, they are useful in controlling the swelling of tissue with fluid and blood – one of the body’s defenses against infection. COPD causes inflammation even though no infectious-agents are present, leading to the breathing problems and later to damage. Corticosteroids function by blocking the effects of the chemicals which the body releases to trigger the inflammatory reaction.
Beta-2 Adrenergic Agonists are chemicals which affect the Beta-2 receptors in cells. An agonist of this type docking with the receptor in cells of the lung-lining causes the smooth muscle tissue to relax, alongside the dilation of the bronchi (the tubes within the lung) and the bronchioles (the sacks of air which facilitate the transmission of oxygen).
Both of these chemicals in combination within the drug offer a treatment wherein the inflammation which is associated with their condition can be alleviated while, simultaneously, the Beta-2 Adrenergic Agonists should relax the lining of the lung, increasing the surface area, allowing the patient to gain more oxygen from the air which they breathe. Thereby, the drug should help to avoid the damage and lessen the discomfort of inflammation and coughing, while lessening the extent to which patients become unnaturally tired due to lack of oxygen. As such, the drug represents a real way in which patients can improve their quality of life if they suffer from lung disease. As with many drugs, it does come with side-effects as noted by the FDA. These include the increased risk of bone-fracture and pneumonia, while the suppression of certain immune-reactions means that patients may be more susceptible to chest and other infections. Given that the drug is certified, these risks are understood to be sufficiently rare for the drug to be safe, while physicians will be able to assess the suitability of a given person.
Overall, this new development represents a step forward for the patients of this long term ailment, allowing them to reduce the symptoms with a more efficient treatment option. It can also be part of the campaign between people, physicians and the government to alleviate the problems which are caused by smoking – both by reducing the amount which people smoke and by managing the diseases which it causes.