GlaxoSmithKline had plans to submit its triple-combo COPD candidate to EU regulators by the end of this year--and now, it has new data in hand to support its application.
Monday, the company announced that the pipeline med had nailed both of its primary endpoints in a Phase III study, topping rival Symbicort from AstraZeneca on metrics measuring lung function and health-related quality of life. The product’s safety profile came up consistent with the known profiles of each of its three component meds, the British drugmaker said.
The top-line results bring the pharma giant one step closer to adding a triple-combo inhaler to its respiratory portfolio--and in doing so, making life easier for patients who currently take three meds dispensed through multiple devices, Dave Allen, the GSK’s respiratory R&D head, said in a statement. “By combining three medicines in a single inhaler we can offer a convenient, once-daily dosing option to patients while improving their symptoms.”
Of course, Glaxo isn’t the only company looking to a triple combo to give it a leg up in the crowded COPD field. Key rivals Novartis and AstraZeneca are each working on their own versions, too.
With time of the essence, though, Glaxo scored a big break earlier this month on the opposite side of the pond: After talks with the FDA, it bumped up its plans to file the combo for U.S. approval, moving the estimated time of its submission from the first half of 2018 to by the end of this year.
- read Glaxo's release
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