After a late 2015 setback at the hands of the FDA, AstraZeneca is back with diabetes med Qtern—and ready to give rivals Eli Lilly and Boehringer Ingelheim some competition.
Tuesday, the FDA approved the combo, which pairs DPP-4 med Onglyza with SGLT2 player Farxiga. The med will now get a chance to take a crack at Lilly and BI’s Glyxambi, a marriage of Tradjenta and Jardiance that’s been on the U.S. market for two years.
AZ, of course, tried to get in the game much earlier, only to see the FDA shoot down Qtern with a request for more clinical data. Since then, though, it has snagged an approval in Europe, winning a first-to-market advantage on that continent.
With its diabetes unit struggling, the British pharma giant could use any boost Qtern can provide. Diabetes “was again weak” in Q4, as Bernstein analyst Tim Anderson put it, with only Farxiga hitting forecasts. Solo Onglyza, for its part, posted a 22% decline.
DPP-4s haven’t had an easy go of it ever since Jardiance showed it could lower the combined rate of heart attack, stroke and cardiovascular death. On the bright side, Farxiga and fellow SGLT2 med Invokana from Johnson & Johnson have been able to ride the “class effect” assumption, though neither challenger has its own outcomes data to prove it--and AZ’s won’t be coming until 2019 at the earliest.
Some DPP-4 drugmakers, though—including Merck, manufacturer of class behemoth Januvia—have pinned their hopes on the combo market. Combinations "really are a part of how we treat diabetes, and not a small part—they're a major part,” Peter Stein, the New Jersey pharma giant’s VP of clinical research in diabetes and endocrinology, said in a 2015 interview, noting that “patients with diabetes need more than one agent, and often more than two agents, to get to goal," he said.
Meanwhile, while AZ waits for its outcomes data, Lilly and BI are working to make the most of their head start. The duo late last year grabbed an indication for reducing CV death, an event that Lilly diabetes president Enrique Conterno predicted would provide a “very significant benefit” for Glyxambi.