GlaxoSmithKline Plc and Theravance Inc.’s respiratory drug Breo Ellipta won U.S. approval to expand its use to treat asthma, though only for patients 18 and older.
The Food and Drug Administration cleared the inhaled medicine, according to a statement from the companies.
Breo was first approved in 2013 to treat chronic obstructive pulmonary disease. Glaxo had sought approval to sell the drug for once-a-day use in patients 12 and older to help control their asthma. The FDA said that the data submitted do not show adequate risk-benefit to support the approval in that age group, the companies said Thursday.
At a meeting with FDA advisers in March, agency staff had questioned whether Breo works better than steroids alone for 12-to 17-year-old asthma patients. Asthma can cause wheezing, shortness of breath and coughing, and affects 25 million people in the U.S., including 7 million children, according to the National Institutes of Health.
Breo is a combination of a steroid and a long-acting beta-agonist, or LABA, called vilanterol. LABAs already on the market come with warnings that some patients who used them had severe episodes of asthma leading to hospitalization or death.
Breo Ellipta and Anoro Ellipta, also approved for chronic obstructive pulmonary disease, are part of a new respiratory franchise that Glaxo has developed. The company intends the products to help make up for an expected decline in sales of its top-selling Advair when the device used to administer the treatment loses patent protection in 2016. Advair is approved for COPD and asthma and generated $7 billion in sales for Glaxo last year, according to data compiled by Bloomberg.