AstraZeneca wins another diabetes approval in a fast-crowding market

AstraZeneca's headquarters in London--Courtesy of AstraZeneca

AstraZeneca ($AZN) won an FDA nod for a one-pill combination of its latest diabetes drug and the long-generic metformin, making it the second to market among a cadre of drugmakers developing similar cocktails.

The drug, to be marketed as Xigduo, pairs AstraZeneca's SGLT2-blocking dapagliflozin with metformin in a once-a-day, extended-release tablet for adults with Type 2 diabetes. Dapagliflozin, approved on its own as Farxiga, works by blocking glucose absorption in the kidneys and leads the body to dispel excess sugars through the urine. Paired with metformin, which decreases glucose production and improves the body's response to insulin, the drug effectively lowered patients' blood sugar levels, the company said.

Thanks to regulatory delays for AstraZeneca and ex-partner Bristol-Myers Squibb ($BMY), rival Johnson & Johnson ($JNJ) was the first mover in SGLT2, winning FDA approval for its canagliflozin last year and securing an August OK for Invokamet, which combines that drug with metformin. The crowded space also includes the tandem of Eli Lilly ($LLY) and Boehringer Ingelheim, which finally won an agency nod for empagliflozin this month. Meanwhile, Pfizer ($PFE) and Merck ($MRK) are working through late-stage trials with the competing ertugliflozin.

However, safety worries have thus far limited uptake for the SGLT2 class, as the treatments have been linked to increased rates of genital and urinary tract infections, plus kidney damage and cardiovascular issues. As a result, peak sales estimates for the class of drugs have been erratic, with some pegging their potential north of $5 billion and others expecting cumulative revenue more in line with $2 billion a year.

The biggest potential for SGLT2 drugs may lie in fixed-dose combinations, and each contender is working up at least one in hopes of boosting its market share. Lilly and Boehringer have submitted a fixed-dose treatment that combines their empagliflozin with linagliptin, a DPP-4 inhibitor marketed as Tradjenta. And Merck and Pfizer have similar goals with their SGLT2 drug, planning to pair it with the former's DPP-4 blockbuster Januvia.

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Special Report: What's next in diabetes drugs? The pulse of R&D at ADA14

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