J&J's diabetes combo wins FDA nod in a fast-crowding space

Johnson & Johnson's ($JNJ) canagliflozin was the first to win FDA approval among a new class of diabetes therapies, and now it's the star of the first such combination therapy to pass agency muster, helping the drug stand out in an increasingly cluttered market.

The new drug, Invokamet, combines the SGLT2 blocker canagliflozin with the commonly prescribed diabetes treatment metformin in a single tablet, a one-two treatment that met its goals of lowering blood sugar and reducing body weight in Phase III trials, J&J said.

Canagliflozin, approved on its own as Invokana last year, works by blocking SGLT2 proteins, stopping glucose absorption in the kidney and leading the body to dispel excess sugars through the urine. Metformin, long since generic, works by decreasing glucose production and improving the body's response to insulin.

Despite its first-mover status in SGLT2, J&J is contending with mounting competition. AstraZeneca ($AZN) picked up FDA approval this year for the similar dapagliflozin, and the tandem of Eli Lilly ($LLY) and Boehringer Ingelheim 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.

But 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.

Like J&J, AstraZeneca is pinning its new drug to metformin, winning EU approval for a combo called Xigduo while its FDA application pends. Lilly and Boehringer, however, have bigger plans for their treatment, in April filing an NDA for a fixed dose combination of empagliflozin and linagliptin, a DPP-4 inhibitor marketed as Tradjenta. Merck and Pfizer have similar goals with their SGLT2 drug, planning to pair it with the former's DPP-4 blockbuster Januvia.

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.

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