Merck and Pfizer prep for battle with SGLT2, combo diabetes filings

Merck building
Merck and Pfizer are looking to break into the SGLT2 battle with ertugliflozin.

Merck and Pfizer may be late to the SGLT2 party, but they’re still trying to make a big entrance.

The drugmakers recently announced that the FDA and EMA had accepted applications not just for SGLT2 diabetes competitor ertugliflozin, but for two combos containing the candidate med, too.

The pair may need the added combo firepower, considering what they’ll be up against. Eli Lilly and Boehringer Ingelheim's Jardiance, Johnson & Johnson's Invokana and AstraZeneca's Farxiga are all far ahead with their contenders in the class.

And it's not just about lead time. Jardiance has additional firepower, thanks to trial data showing it can cut the combined risk of heart attack, stroke and cardiovascular death. Last December, the med nabbed a new FDA-approved use based on that data, and now can market Jardiance as a tool to cut diabetics' risk of cardiovascular death. The other two drugs in the class are on their way to CV risk data, too; J&J wraps its own outcomes trial later this year, while AZ finishes its own in 2019.

RELATED: Merck, Pfizer amp up ertugliflozin outcomes study as SGLT2 med scores in PhIII

Merck and Pfizer are well aware of that pressure. After Jardiance's big success last year, the companies said they'd double the size of their ertugliflozin outcomes trial—primarily designed to measure CV safety—to 8,000 patients and add two new secondary endpoints. "We are expanding it further so we can properly power it to measure a cardiovascular benefit," former company VP of clinical research in diabetes and endocrinology, Peter Stein, said at the time.

Meanwhile, Merck and Pfizer's ertugliflozin combo meds will have plenty of competition, too. If approved, the ertugliflozin-metformin pairing will face off against J&J’s Invokamet, which merges Invokana and metformin, and Lilly’s similar Jardiance duo, Synjardy.

Merck and Pfizer’s second combo—which matches ertugliflozin with Merck's DPP-4 stalwart Januvia—will have its own head-to-head rivals. Lilly’s Glyxambi combines Jardiance with its DPP-4 med Tradjenta, while AZ’s newly approved Qtern combines Farxiga with its own Onglyza.

RELATED: AstraZeneca scores diabetes combo win, but can it keep up with Lilly and BI?

Still, the DPP-4 combo is where Merck and Pfizer might find their SGLT2 edge. Januvia is far and away the leading DPP-4 med, and Merck will be working hard to keep Januvia competitive as prescription trends shift.

In fact, the potential for a Januvia combination is one reason why Merck jumped into the SGLT2 field, Stein told FiercePharma at last year's American Diabetes Association meeting. "Januvia is a go-to drug that doctors are comfortable with, and it's exciting to have a new SGLT2 with a different profile and potentially complementary mechanism," he said.

Plus, as Stein pointed out shortly after Lilly and BI's first Jardiance announcement, combo meds "really are a part of how we treat diabetes, and not a small part—they're a major part. Patients with diabetes need more than one agent, and often more than two agents, to get to goal."