Glaxo Gains FDA Approval for New once a day Inhaler

The U.S. Food and Drug Administration approved a GlaxoSmithKline/Theravance Inc inhaler drug for treating chronic obstructive pulmonary disease or COPD.

The inhaler drug, Breo Ellipta, is to be taken just once per day. The FDA gave approval of Breo for those suffering from COPD or smoker’s cough.

The disease currently ranks third in the U.S. for cause of death, according to data from the U.S. Center for Disease Control’s National Lung, Heart and Blood Institute. The recent report says close to 24 million people living in the U.S are affected by COPD but just 50% are being diagnosed.

The approval of Breo Ellipta by the FDA could make life easier for some patients with COPD, which is caused mainly from smoking resulting in part of the lungs’ airways becoming partially obstruction. Glaxo called the medicine cost effective.

The contents of Breo Ellipta, including fluticasone furoate and corticosteroid help to decrease the inflammation in the lung and vilanterol, an active ingredient helps to open the airways in the lung. The new drug will help as a complementary product to Advair, the best selling drug for asthma from GSK. Advair has annual sales of close to $8 billion.

Outside the United States, Breo will be packaged under the name Relvar. Its once per day dosage should be attractive to more patients as compared to other drugs that are similar including the twice per day AstraXeneca.

Breo was not approved to treat asthma and the drug contains a box warning saying so. Possible side effects, said the FDA, include pneumonia, bone fractures, nasal swelling, headaches and upper respiratory infection.



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