LONDON (Alliance News) - GlaxoSmithKline PLC on Friday said it has received a positive opinion on broadening the use of its Trelegy Ellipta inhaler in patients with chronic obstructive pulmonary disease.
This opinion comes from the European Medicines Agency's Committee for Medicinal Products for Human Use, and would see the labelling for the drug modified to encompass a broader group of patients with moderate to severe forms of the disease.
Trelegy contains a combination of three drugs intended to treat chronic obstructive pulmonary disease. This disease creates breathing difficulties, and is caused by inhaling irritants such as cigarette smoke and air pollution.
The European committee issued a positive position on Trelegy's label being expanded to use in patients who are not adequately treated by a combination of two other types of drug. New labelling would also make reference to the inhaler's effect on exacerbations, based on the results from Glaxo's IMPACT study.
"Many patients with chronic obstructive pulmonary disease continue to experience exacerbations despite taking dual bronchodilator therapies. The landmark IMPACT study provided compelling evidence on the role Trelegy Ellipta can play in reducing these debilitating events. If approved, the indication will recognise this," said Glaxo Chief Scientific Officer Hal Barron.
Shares in Glaxo were up 1.1% at 1,503.20 pence on Friday.
Glaxosmithkline (GSK)