Sanofi's new diabetes drug is finally ready for FDA scrutiny

Sanofi ($SNY) is on track to resubmit its latest treatment for Type 2 diabetes after years of delay, as the drug came through on a long-term safety study designed to quell FDA concerns.

The treatment, lixisenatide, is designed to bolster the hormone GLP-1 and promote the body's natural production of insulin, lowering blood sugar and body weight in the process. The drug's efficacy has already been established, but Sanofi yanked its FDA application in 2013 just as the FDA was tightening its focus on the safety of new diabetes treatments. That same year, rival Novo Nordisk ($NVO) endured a surprise rejection for its latest long-acting insulin, and Sanofi figured its best bet was to establish lixisenatide's safety before handing the drug to regulators.

Now those data are in, and Sanofi likes what it sees. In a 5-year study on more than 6,000 diabetics, patients taking lixisenatide were no more likely to suffer heart attacks, strokes or other cardiovascular events than those on placebo. The drug also charted no increased risk for heart failure, pancreatitis, pancreatic cancer or severe symptomatic hypoglycemia.

That gives the French drugmaker confidence to get lixisenatide back on the path to regulatory approval, and Sanofi expects to resubmit the drug in the third quarter of this year. Lixisenatide is already on the market in Europe as Lyxumia.

The study results make lixisenatide the only GLP-1 treatment to have established its safety in a long-term trial, a benefit Sanofi bets will help the drug contend with its well-entrenched competitors in the space.

Dr. Marc Pfeffer

"People around the world are being treated with GLP-1 receptor agonists, and the (cardiovascular) effects were unknown," lead investigator Dr. Marc Pfeffer said in a statement. "(The trial) goes beyond the FDA guidance to deliver data related to heart failure and other insights that are not currently available for any other GLP-1 receptor agonist."

Meanwhile, as lixisenatide has been on the mend these years, the world's biggest GLP-1 treatment, Novo's Victoza, has swelled into a $2 billion-a-year product. And Eli Lilly ($LLY) has made its way to market with Trulicity, a once-a-week option that has measured up to Novo's blockbuster in Phase III trials.

Each contender has ambitions of pairing its GLP-1 agonist with a long-acting insulin, but clinical and regulatory setbacks have led to delays for all involved. The FDA's rejection of Novo's new insulin, Tresiba, pushed back indefinitely the company's plans to market a Victoza-led combination called Xultophy in the U.S. While Lilly, already on the market with Trulicity, has run into serious safety problems with its latest insulin, putting off an FDA filing until it can better understand the treatment's effect on liver health. And Sanofi will have to wait for a final word on lixisenatide before it can move forward with an insulin combo of its own.

- read the statement

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