11th Sep 2013 07:19
LONDON (Alliance News) - GlaxoSmithKline PLC Wednesday said a US Food and Drug Administration advisory committee had recommended the approval of a pulmonary disease drug, which it will call Anoror Ellipta, for treatment of chronic obstructive pulmonary diseases including chronic bronchitis and emphysema, clearing the way for full clearance.
The pharmaceuticals giant said the FDA's Pulmonary-Allergy Drugs Advisory Committee voted 11 to 2 in favour that the efficacy and safety data provide substantial evidence to support approval of the drug for long-term, once daily treatment using a bronchodilator.
The drug is a combination of two investigational bronchodilator molecules: GSK573719 or umeclidinium bromide, a long-acting muscarinic antagonist, and vilanterol, a long-acting beta2 agonist, administered using the Ellipta inhaler.
It is currently an experimental treatment and FDA approval would mark its first clearance anywhere in the world.
"If approved, Anoro Ellipta will be the first, once-daily dual bronchodilator available in the US, marking another significant milestone for GSK's portfolio of medicines to treat respiratory disease," the company's president of pharmaceuticals research and development said in a statement.
GlaxoSmithKline shares were up 0.02% at 1,598.895 pence early Wednesday.
By Steve McGrath; [email protected]; @SteveMcGrath1
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