First-In-Class Diabetes Drug Approved

First-In-Class Combo Diabetes Drug Approved

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On February 2, the U.S. Food and Drug Administration (FDA) approved the first-in-class combination oral diabetes drug Glyxambi for use, along with a healthful diet and exercise, in adults with Type 2 diabetes. The medicine, a development of Boehringer Ingelheim Pharmaceuticals and Eli Lilly and Company, combines empagliflozin (brand name Jardiance), an SGLT2 inhibitor, and linagliptin (Tradjenta), a DPP-4 inhibitor.

In the process of filtering the blood, the kidneys typically reabsorb all the filtered glucose and return it to the bloodstream. One of the main proteins responsible for this reabsorption is SGLT2. By inhibiting the action of SGLT2, empagliflozin blocks the reabsorption of glucose by the kidneys, promoting a loss of glucose in the urine and lowering blood glucose levels.

DPP-4 inhibitors such as linagliptin work to lower blood glucose by blocking the action of an enzyme known as dipeptidyl peptidase 4, or DPP-4. DPP-4 breaks down hormones called incretins, which stimulate the release of insulin, slow stomach emptying, inhibit the release of glucagon (a hormone that signals the liver to release glucose), and enhance the survival and growth of the insulin-producing beta cells. With DPP-4 inhibited, the incretins have longer to carry out these actions.

Glyxambi, which is the first combination tablet of a DPP-4 inhibitor and an SGLT2 inhibitor approved in the United States, will be offered in doses of 10 milligrams or 25 milligrams of empagliflozin with 5 milligrams of linagliptin, to be taken once a day in the morning.

This medicine should not be used in people who have Type 1 diabetes, diabetic ketoacidosis (a potentially life-threatening condition marked by a chemical imbalance in the body), severe kidney problems, or in those who are on dialysis. The most commonly reported side effects of Glyxambi are urinary tract infection, nasopharyngitis (inflammation of the nose and pharynx), and upper respiratory tract infection.

For more information about Glyxambi, see the press releases on the Eli Lilly website or the medicine’s official website.

Inhalable Insulin Now Available
In other news, the inhalable insulin/inhaler combination Afrezza, developed by MannKind Corporation and licensed by pharmaceutical company Sanofi, is now available to U.S. consumers by prescription in retail pharmacies nationwide. Afrezza, which was approved by the FDA in June 2014, is comprised of an ultrarapid-acting premeal insulin powder and a whistle-size device that the powder is loaded into for inhalation.

To learn more about Afrezza, click here or see the official website.

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