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FDA Expands Use for Synjardy to Type 2 Diabetes Treatment for First Time Adults

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FDA Expands Use for Synjardy to Type 2 Diabetes Treatment for First Time Adults
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Boehringer Ingelheim’s and Eli Lilly and Company’s joint product, Synjardy (empagliflozin and metformin hydrochloride,) has received U.S. Food and Drug Administration (FDA) approval for an expanded indication to include treatment-naïve (first time treated) adults with from Type 2 diabetes (T2D).

Synjardy is a prescription medicine, indicated as an addition to exercise and diet, to improve glycemic control in T2D adult patients. It contains two complementary diabetes medicines: empagliflozin, a sodium glucose co-transporter-2-inhibitor that helps in the elimination of excess glucose through urine by blocking its re-absorption in the kidney; and metformin, a commonly prescribed initial therapy for T2D patients that lowers glucose production in the liver and glucose absorption in the intestine.

Synjardy is not indicated for any other type of diabetes.

It is estimated that 29 million Americans have diabetes and 415 million have the disease worldwide. It is estimated that 12% of all people in the U.S. aged 20 and older are diabetic and nearly 28% of people with diabetes are still not diagnosed.

The most common T2D accounts for nearly 90% of all diagnosed adults. It requires careful diet and exercise attention in addition to demanding daily medicine routines.

“Type 2 diabetes is a complex condition, which often requires that people take more than one treatment to manage their blood sugar,” Paul Fonteyne, Boehringer’s president and chief executive officer, said in a press release. “The expanded indication for Synjardy further validates the potential of this combination therapy to help adults with Type 2 diabetes that are not at goal, including those already being treated and now also those at the beginning of their treatment journey.”

Synjardy’s label now includes results from a Phase 3, randomized, double-blind, active-controlled clinical trial that assessed the safety and efficacy of the drug as an initial therapy, in comparison with the single administration of its components (empagliflozin and metformin).

In the 24-week study, the combination of empagliflozin 10 mg or 25 mg with metformin 1,000 mg or 2,000 mg led to significant reductions in A1C (a measurement of average blood glucose over the past two to three months) when compared with the corresponding dose of the drugs given independently.

Synjardy can now be used by T2D patients who are already under treatment or who will be starting diabetes treatment for the first time.

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