FDA advisors have voted in favour of approving GlaxoSmithKline/Theravance's chronic obstructive pulmonary disease treatment Anoro Ellipta, but have called for a post-marketing study in patients with more severe cardiovascular disease.
Anoro Ellipta is a combination of two investigational bronchodilator molecules - the long-acting muscarinic antagonist (LAMA) umeclidinium bromide (UMEC), and the long-acting beta2 agonist (LABA) vilanterol (VI), delivered through the Ellipta inhaler.
The indication under review is for the long-term, once-daily, maintenance bronchodilator treatment of airflow obstruction in patients with COPD, including chronic bronchitis and emphysema.
While the decision was not unanimous it was heavily weighted in the product's favour, with members of the Pulmonary-Allergy Drugs Advisory Committee to the US Food and Drug Administration voting 11 yes to two no that the efficacy and safety data provide substantial evidence to support its approval.
Decision in December
A final decision from the FDA is expected by December 18 this year and, if approved, Anoro Ellipta will be the first, once-daily dual bronchodilator available in the US.
Nearly 15 million US adults have COPD and another 12 million are undiagnosed or developing the condition, and analysts believe Anoro Ellipta has the potential to attain blockbuster status, pulling in sales of over $2 billion a year by 2018, according to a forecast average compiled by Thomson Reuters.
US regulators recently gave a full green light to another GSK/Theravance COPD drug called Breo Ellipta, a combo of VI and the corticosteroid fluticasone furoate that is also tipped to quickly become a blockbuster with sales fast approaching $2 billion in five years.