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F.D.A. Panel Splits on Whether to Approve New Diabetes Drug

F.D.A. Panel Splits on Whether to Approve New Diabetes Drug
Health|F.D.A. Panel Splits on Whether to Approve New Diabetes Drug

The advisory committee voted 8-8 on approving the drug, to be called Zynquista, which would be the first oral medication for people with Type 1 diabetes.

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The drug makers Sanofi and Lexicon Pharmaceuticals are seeking F.D.A. approval for the first oral treatment for Type 1 diabetes.CreditCreditChristian Hartmann/Reuters

An advisory panel for the Food and Drug Administration split evenly on Thursday over whether the agency should approve the first oral medication to treat Type 1 diabetes.

The committee voted 8-8, leaving it up to the agency to decide by the end of March whether the drug, sotagliflozin, should reach the market.

The drug, which is used along with insulin, is being developed by the drug makers Sanofi and Lexicon Pharmaceuticals, who plan to sell it under the brand name Zynquista. It carries a higher risk for developing diabetic ketoacidosis, a life-threatening complication that happens when the body doesn’t get enough insulin, which led some of the reviewers to vote against it.

The companies said they would continue work with the F.D.A. throughout the review process.

The drug is a once-daily pill designed to help people manage their blood sugar levels. In Type 1 diabetes — also known as juvenile diabetes because it is often diagnosed in childhood — the body does not produce insulin, so people with the disease must monitor their blood sugar and take insulin. But relying on external insulin can lead the body’s blood sugar levels to rise and fall, which is uncomfortable and can lead to health problems.

Like some other recently approved drugs for people with Type 2 diabetes — including Invokana and Jardiance — this one causes the body to excrete more blood sugar into the urine.

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The drug’s approval would be based on the results of three clinical trials involving about 3,000 people. The trials found that the drug helped patients manage their blood sugar levels and brought other benefits, such as lower blood pressure and some weight loss.

But among patients who were given the drug, there were 56 cases of diabetic ketoacidosis in 1,748 patients, or 3.2 percent. In patients who took the placebo, by contrast, there were 5 cases out of 1,229 patients, or 0.4 percent.

Diabetic ketoacidosis, which is always a risk for people with Type 1 diabetes, can result in serious hospitalization or death. Several panel members said they worried the risk could be even higher in the real world, outside the confines of a clinical trial.

“I didn’t think it was ready for prime time,” said Dr. Jack A. Yanovski, of the National Institutes of Health, who voted against it. “The degree of benefit is small enough that it’s not clear that it could overwhelm the increased risk for very serious complications.”

But others said patients with Type 1 diabetes needed new treatments. Several patients who had received the drug in the clinical trial testified at the meeting, saying it had improved their quality of life. “It’s a step in the right direction,” said Susan Lellock, the panel’s patient representative, who voted in favor of approval. “With guidance, they need this. They need it desperately.”

Several panel members, including those who voted both for and against its approval, said the F.D.A. should require the drug makers to sell the drug under a strict plan for how patients should be monitored and educated about the risks of taking the drug.

Although the vast majority of Americans with diabetes have Type 2 diabetes, about 1.25 million people in the United States have Type 1, and an estimated 40,000 people each year will be diagnosed with it, according to the American Diabetes Association.

Diabetes drugs have come under a different kind of scrutiny because of the price of insulin, which has skyrocketed in recent years and led some patients to cut back on using it. Sanofi declined to comment on the potential price of Zynquista if it is approved.

Sheila Kaplan contributed reporting.

More reporting on Diabetes

Katie Thomas covers the business of health care, with a focus on the drug industry. She started at The Times in 2008 as a sports reporter. @katie_thomas

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F.D.A. Advisers Split on Recommending Approval of the First Oral Drug for Diabetes

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