Merck's new lung drug wins FDA approval
London, June 24, 2010
Merck & Co's new two-in-one respiratory drug Dulera has been approved by the US
Food and Drug Administration, the US company said on Thursday, confirming an earlier Reuters report.
The inhaled treatment has been cleared for treating asthma in patients 12 years of age and older. It is not indicated for the relief of acute bronchospasm.
The fixed-dose combination of mometasone furoate and formoterol fumarate was developed by Schering-Plough and inherited by Merck when it acquired its smaller rival last year.
The new product combines the dual action of an inhaled corticosteroid and a long-acting beta agonist (LABA) to improve lung function in asthma sufferers.
It is a rival for GlaxoSmithKline's market-leading Advair and AstraZeneca Plc's Symbicort, both of which act in a similar way.
Recently, the FDA has taken a critical look at LABA drugs, drawing up new warnings earlier this month for the inhaled treatments. Some analysts said the issues over LABA safety may have delayed the FDA's decision on Dulera, which had initially been expected by April.
In the end, the agency gave a green light for the medicine ahead of the manufacturer by revealing in an update on its website that approval had been granted, before Merck issued a press release.
Merck said it expected Dulera to be available in retail pharmacies across the United States by the end of July 2010. The drug is also being developed as a treatment for chronic obstructive pulmonary disease. - Reuters