An advisory committee of FDA has voted the recommendation to approved GSK’s next-generation respiratory drug, with optimisms of capturing half of the $6 billion market industry in the United States.
The U.S. Food and Drug Administration has granted approval for pharmaceutical giant GlaxoSmithKline (NYSE: GSK) to market Breo Ellipta as treatment for Chronic Obstructive Pulmonary Disease (COPD).
In a company’s thrust to market the drug to a broader patient population, GSK seeks approval to use Breo for treatment of asthma as well, an ailment that somehow affects over 26 million people in the U.S. alone, 18.7 million of which are adults.
Currently manufactured in Ware, United Kingdom, plan is underway however, to move Breo production to Zebulon later this year, even though a recommendation from the advisory panel no way guarantees approval from FDA.
“We will continue to work closely with the FDA while it considers the committee’s recommendations and our aim is to answer any outstanding questions to enable them to make a fully informed decision,” says Darrell Baker, senior vice president and head of GSK Global Respiratory Franchise.
Specifically called the $6 billion ICS/LABA respiratory market, Breo would be the only ICS/LABA with once a day dosage and is administered via the new Ellipta inhaler, if approved.