The Food and Drug Administration has approved an inhaler drug jointly manufactured by British pharmaceutical GlaxoSmithKline Plc and Theravance Inc of the United States for the treatment of chronic obstructive pulmonary disease (COPD).
GlaxoSmithkline's Breo Ellipta is an inhaler drug, to be taken once- a-day, which helps in the treatment of chronic obstructive pulmonary disease (COPD). FDA approved the use of Breo for patients suffering from COPD or in common parlance smoker's cough.
This pulmonary disease is currently ranked the third leading cause of death in the U.S., according to the United States Centers for Disease Control and Prevention and National Heart, Lung, and Blood Institute. The report says nearly 24 million Americans are affected by the disorder but only half of those are being diagnosed.
"COPD is a serious disease that makes breathing difficult," Curtis Rosebraugh, M.D., M.P.H., director, Office of Drug Evaluation II, Center for Drug Evaluation and Research, FDA, said in a press release. "The availability of new long-term maintenance medications provides additional treatment options for the millions of Americans who suffer with COPD."
FDA's approval for Breo Ellipta could ease life for patients with COPD, which is mainly caused due to smoking resulting in the partial obstruction of lungs' airways. Glaxo claims the medicine is cost effective
Breo Ellipta includes corticosteroid, fluticasone furoate, which helps decrease lung inflammation and a new active ingredient to open lungs' airways called vilanterol. The new inhaler drug will serve as a complementary product to GSK's best selling asthma drug, Advair, which includes salmeterol as an active ingredient.
GSK's Advair brings annual revenue of nearly $8 billion.
Breo will be sold outside the U.S. as Relvar. Its one-time a day dosage should attract more patients compared to other similar drugs including AstraZeneca's, which are needed twice a day.
Breo contains a boxed warning of not to be used as treatment for asthma.
"The safety and efficacy of Breo Ellipta in patients with asthma have not been established and it is not approved for the treatment of asthma," the FDA said in a statement. According to FDA, possible side effects may include increased risk of pneumonia and bone fractures and it was commonly noticed that patients using Breo were exposed to nasal passage swelling, upper respiratory tract infections, headaches and oral candidiasis.
