GSK's closed triple COPD prospect is in early to regulators. Next step? 'Clinch the market'

GlaxoSmithKline has submitted its closed triple COPD therapy to the FDA for review.

Eighteen months ahead of schedule, the application for GlaxoSmithKline’s closed triple combination COPD therapy is in to U.S. regulators. And the way the British drugmaker sees it, that’s an 18-month head start it can get on what CEO Andrew Witty has called a “share-take opportunity.”

GSK announced Monday that it had handed over its app for the cocktail, which comprises ICS fluticasone furoate, LAMA umeclidinium and LABA vilanterol and is delivered via the company’s Ellipta inhaler. Glaxo, which initially planned to submit its materials to the agency in the first half of 2018, said in June that it had bumped up that timeline and pledged to get them in by year’s end.

Now, the company is that much closer to a weapon that could put it ahead of a slew of drugmakers coming at it with double combos, including AstraZeneca, Novartis and Boehringer Ingelheim. And it could put it far ahead, Witty said on the company’s Q2 conference call.

He likened today’s respiratory landscape to that of 20 years ago, just before the launch of GSK’s megablockbuster, Advair. At the time, monotherapies reigned, but when Advair came along, it “really drove the dominance of GSK in that space,” Witty said. “It took Astra then another five or six years to try and catch up, and they have never really been able to, in terms of share.”

And it’s that kind of opportunity he’s foreseeing for the triple, which he believes will be “the thing that really clinches the market.”

“I think if you decide that your triple of choice is the GSK triple, then why wouldn't you start with a double of GSK? Why on earth would you start with somebody else's double?” he asked on the call.

Clinching that competitive market isn’t exactly going to be a cake walk though, and Glaxo knows it. One-third of the COPD market is currently receiving an open triple therapy that employs multiple devices. But GSK might only be playing in about half of those prescriptions right now, Witty pointed out.

That makes for “a relatively small fraction of the total value of that marketplace. So the first thing of course, is to try and capture more of that,” he said.

Another benefit to the bumped-up filing is that GSK has minimized—or potentially eliminated—the gap between when generic competition to Advair arrives and when the closed triple hits the scene. While it’s still unclear whether knockoff makers will be able to cinch go-aheads on their first tries, Mylan and Hikma are both expecting FDA decisions on their versions of the giant in the first half of next year.