FDA
13th December 2013

FDA Panel Recommends Approval for dapagliflozin

Yesterday, the U.S. Food and Drug Administration’s (FDA) Endocrinologic and Metabolic Drugs Advisory Committee (EMDAC) voted 10-4 in favor of the updated cardiovascular risk profile of the investigational sodium-glucose co-transporter (SGLT2) inhibitor, dapagliflozin  (Bristol-Myers/AstraZeneca). The committee also voted 13-1 in favor of the agent as an adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes.

FDA Panel Recommends Approval for dapagliflozin

Yesterday, the U.S. Food and Drug Administration’s (FDA) Endocrinologic and Metabolic Drugs Advisory Committee (EMDAC) voted 10-4 in favor of the updated cardiovascular risk profile of the investigational sodium-glucose co-transporter (SGLT2) inhibitor, dapagliflozin  (Bristol-Myers/AstraZeneca). The committee also voted 13-1 in favor of the agent as an adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes.

In 2011, the EMDAC voted against approval of dapagliflozin for type 2 diabetes over safety concerns regarding possible increased risk of breast or bladder cancer. Following this outcome, the drug company followed the direction of the FDA and sought additional data that would better demonstrate the drug’s benefit-risk profile. 

During this meeting, the EMDAC was provided with data from the extensive dapagliflozin global clinical development program included as part of the New Drug Application (NDA) and resubmission. In response to the FDA’s Jan. 2012 complete response letter, the NDA resubmission included several new studies and additional long-term data (4 years) from previously submitted studies, resulting in an overall increase in patient-years exposure to dapagliflozin of more than 50 percent as compared to exposure in the original NDA. The resubmission included data from the dapagliflozin Phase II/III clinical development program, which included more than 11,000 adult patients with diabetes (approximately 6,000 patients received dapagliflozin) in 24 clinical trials.

Type 2 diabetes is a chronic disease characterized by several pathophysiologic defects, including insulin resistance and dysfunction of pancreatic beta cells, leading to elevated glucose levels (hyperglycemia). Over time, sustained hyperglycemia contributes to further progression of the disease. Significant unmet needs still exist, as many patients remain inadequately controlled on their current glucose-lowering regimen as it is difficult and inconvenient to monitor or anticipate fluctuations in blood sugar. Diabetes is estimated to affect 26 million people in the U.S. and more than 382 million people worldwide. The prevalence of diabetes is projected to reach more than 592 million people worldwide by 2035. Type 2 diabetes accounts for approximately 90-95 percent of all cases of diagnosed diabetes.

Dapagliflozin is a SGLT2 inhibitor (found predominantly in the kidney), which reduces resorption of glucose in the kidney, resulting in increased urinary glucose excretion, consequently lowering plasma glucose levels and promoting weight loss. The kidney plays an important role in maintaining normal glucose balance, in part by filtering and subsequently reabsorbing glucose back into circulation. In patients with type 2 diabetes, the capacity of the kidney to reabsorb glucose is increased by approximately 20-30 percent, further exacerbating the hyperglycemia associated with the disease. Selective inhibition of SGLT2 reduces the reabsorption of excess glucose and enables its removal via the urine.

Dapagliflozin is currently approved for the treatment of type 2 diabetes in several countries including the European Union, Australia, Brazil, Mexico and New Zealand.

Harold E. Bays, MD, FTOS, FACE, FNLA, medical director and president of the Louisville Metabolic and Atherosclerosis Research Center Inc. expressed the need for more diabetic treatment options stating that, “Diabetes remains an epidemic with significant morbidity and mortality. Improvements in metabolic parameters as associated with improved outcomes. Numerous treatment options are available but each has its limitations; a need remains for new therapeutic options.”

The FDA is not bound by the EMDAC’s decision but normally follows its recommendation.

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