FDA accepts Merck's JANUMET extended-release formulation NDA for type 2 diabetes

Merck today announced that the New Drug Application (NDA) for the Company's investigational extended-release formulation of JANUMET for type 2 diabetes has been accepted for standard review by the U.S. Food and Drug Administration (FDA). The Company is also moving forward as planned with regulatory filings in countries outside the United States.

“What is the most important information I should know about JANUMET?”

The extended-release formulation of JANUMET is an investigational treatment for type 2 diabetes that combines sitagliptin, which is the active component of JANUVIA® (sitagliptin), with metformin extended release, a commonly-prescribed medication for type 2 diabetes, into a single tablet. This formulation is designed to provide a new treatment option for healthcare providers and patients who need two or more oral agents to help control their blood sugar with the convenience of once daily dosing.

Sitagliptin is the most widely prescribed DPP-4 inhibitor. An immediate release formulation of JANUMET is already available.

JANUMET is indicated, as an adjunct to diet and exercise, to improve glycemic control in adults with type 2 diabetes mellitus when treatment with both sitagliptin and metformin is appropriate. JANUMET should not be used in patients with type 1 diabetes or for the treatment of diabetic ketoacidosis. JANUMET has not been studied in patients with a history of pancreatitis. It is unknown whether patients with a history of pancreatitis are at increased risk for the development of pancreatitis while using JANUMET.

"The filing of the extended-release formulation of JANUMET demonstrates Merck's commitment to providing novel treatment options to people with type 2 diabetes who need them," said Barry J. Goldstein, M.D., Ph.D., vice president of Clinical Research, Merck Research Laboratories. "The majority of patients with type 2 diabetes require multiple therapies to control their blood sugar. With the approval of the extended-release formulation of JANUMET, Merck would have the only DPP-4 inhibitor in combination with both immediate-release metformin and extended-release metformin, giving healthcare providers more options to treat their patients with type 2 diabetes."

DPP-4 inhibitors and metformin work in a complementary manner to lower glucose. Metformin is the most commonly used first-line treatment. DPP-4 inhibitors work by enhancing a natural body system called the incretin system to help regulate blood sugar by increasing levels of active GLP-1 and GIP hormones.

JANUMET is contraindicated in patients with renal disease, renal dysfunction, or abnormal creatinine clearance; and acute or chronic metabolic acidosis, including diabetic ketoacidosis with or without coma; or history of a serious hypersensitivity reaction to JANUMET or sitagliptin, such as anaphylaxis or angioedema. The labeling for JANUMET contains a boxed warning for lactic acidosis, a rare, but serious, metabolic complication that can occur due to metformin accumulation during treatment with JANUMET.

When JANUMET was used in combination with a sulfonylurea or insulin, medications known to cause hypoglycemia, the incidence of hypoglycemia was increased over that of placebo. Therefore, a lower dose of sulfonylurea or insulin may be required to reduce the risk of hypoglycemia.

There have been postmarketing reports of acute pancreatitis, including fatal and nonfatal hemorrhagic or necrotizing pancreatitis, in patients taking JANUMET. After initiating JANUMET, patients should be observed carefully for signs and symptoms of pancreatitis. If pancreatitis is suspected, JANUMET should be promptly discontinued and appropriate management initiated. It is unknown whether patients with a history of pancreatitis are at increased risk of developing pancreatitis while taking JANUMET.

Source:

 Merck

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