GSK and Theravance see FDA nod for asthma indication
An FDA panel has recommended the approval of asthma treatment Breo Ellipta in adults – but voted against supporting its use in children.
The FDA’s pulmonary allergy drugs advisory committee and drug safety and risk management wing voted to recommend the approval of the asthma drug, which is co-marketed by GSK and Theravance, as a once-daily inhaled treatment for asthma in patients aged 18 years and older.
But the committees turned down the companies’ application for a license in children aged 12 to 17 because of a lack of efficacy data.
They recommended GSK and Theravance conduct a large safety trial in both age groups similar to the ongoing safety trials being conducted as an FDA post-marketing requirement by the manufacturers of other long-acting beta-agonists – the same class of asthma treatments contained in Breo Ellipta: Glaxo's Advair (fluticasone propionate), AstraZeneca's Symbicort (budesonide/formoterol fumarate dihydrate) and Merck's Dulera (mometasone/formoterol) and Foradil (formoterol fumarate), in both adolescents and adults.
Analysts predict $750 million in Breo sales by 2020, and the FDA is expected to rule on whether to approve the drug by the end of April this year.
Darrell Baker, senior vice president and head of GSK’s global respiratory franchise, says: “We recognise the advisory committee’s thoroughness in reviewing the data related to Breo Ellipta for asthma. 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.”
Michael Aguiar, president and chief executive of Theravance says: "We remain committed to the ongoing review process and will be fully cooperating with the FDA to ensure it has all it needs to consider the application for Breo Ellipta in asthma. We look forward to the final outcome expected in April.”