Glaxo, Theravance's Breo Ellipta Asthma Drug gets Approval from US FDA
The sale of Breo Ellipta has got approval from the US Food and Drug Administration as a once-daily treatment for asthma in patients aged 18 and older, said GlaxoSmithKline and Theravance Inc.
The FDA said the treatment could not be approved for use in younger asthma sufferers as it's not safe for them. The agency said that only additional data could confirm Breo's safety and efficacy in that population.
The FDA gave its nod to the treatment after an FDA advisory panel of experts had voted 16-4 for use in adults. However, it voted 19-1 that data was not substantial enough to prove that it's safe for use in children aged 12 to 17.
The companies said that Breo Ellipta is not meant for providing relief from acute bronchospasm. According to forecast of Bernstein analyst Tim Anderson, sales of Breo would touch $750 million mark in 2020.
A corticosteroid is present in the drug to reduce inflammation and the airways are opened by a long-acting beta-agonist called vilanterol.
The previous approval of the inhaled treatment was intended for treatment of chronic obstructive pulmonary disease, or COPD, a condition that includes emphysema, chronic bronchitis or both.
The FDA issued a complete response letter to mention that Breo Ellipta should not be used in patients aged 12-17 because available data did not show that it is beneficial enough to go ahead with the approval in these patients.
Breo is approved in two strengths, 100/25mcg and 200/25mcg, in the US for treating asthma. And it is meant to administering once-daily using the Ellipta dry powder inhaler.