Glaxo stokes triple-combo hopes with data topping AZ's Symbicort


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.”  

Free Webinar

What could you do with real-time supply chain information at your fingertips?

Interested in complete supply chain real-time data visibility? Unlock productivity with digital workflows, manage plants inventory with real-time supply chain information and enable faster decision-making with data visualization with pci | bridge. Register today!

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 

Special Reports: The top 15 companies by 2014 revenue - GlaxoSmithKline 

Related Articles:
Wannabe generic Advair makers Mylan, Vectura aim for 'rational' drug pricing
GSK finally has Breo where it wants it--just in time for Advair copies
GSK shoots for diabetes-esque platform approach with new respiratory med in hand
Novartis hopes Seretide-topping data can push docs toward Ultibro
Boehringer faces uphill battle for Stiolto, thanks to payer arm-twisting

Suggested Articles

With a slate of vaccine authorizations on the horizon, vaccine execs from a trio of leading shot makers are looking at distribution hurdles ahead.

News of an FDA plant inspection for a Macrogenics drug boosted investor confidence in BMS' ability to meet its year-end deadline for liso-cel.

BioCryst has scored FDA approval for Orladeyo, the first oral option to prevent hereditary angioedema attacks in patients 12 and older.