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FDA Approves Farxiga, AstraZeneca and Bristol-Myers Squib New Type 2 Diabetes Treatment

The U.S. Food and Drug Administration (FDA) has approved AstraZeneca and Bristol-Myers Squib new type 2 diabetes treatment, Farxiga (dapagliflozin), a once-daily oral treatment indicated as an adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes.

FDA Advisory Committee Votes In Favor of NewType 2 Diabetes Drug, Dapagliflozin.

The FDA's Endocrinologic and Metabolic Drugs Advisory Committee (EMDAC) has decided (13-1) in favor of Bristol-Myers Squib and AstraZeneca's type 2 diabetes drug, dapagliflozin. The committeee found that the benefits of dapagliflozin use outweigh identified risks and support marketing of dapagliflozin as an adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes mellitus.

AstraZeneca and Bristol-Myers Squibb Resubmit New Type 2 Diabetes Treatment for FDA Approval

AstraZeneca and Bristol-Myers Squibb Company resubmitted a New Drug Application (NDA) to the U.S. FDA for the investigational drug dapagliflozin for the treatment of adults with type 2 diabetes. The FDA assigned a new Prescription Drug User Fee Act (PDUFA) goal date of Jan. 11, 2014.

Experimental Diabetes Drug Shows Improved Glycemic Control

A new study evaluating the efficacy and safety of adding dapagliflozin therapy to the treatment of type 2 diabetes patients whose blood glucose levels remain poorly controlled despite high doses of insulin was published today in the Annuls of Internal Medicine...

FDA Requests Additional Data on Type 2 Diabetes Drug Dapagliflozin

The FDA has issued a complete response letter regarding the New Drug Application (NDA) for investigational compound dapagliflozin for the treatment of type 2 diabetes in adults submitted by Bristol-Myers Squibb Company and AstraZeneca...

FDA Advisory Committee Votes Against Type 2 Diabetes Drug Dapagliflozin

The U.S. Food and Drug Administration's (FDA) Endocrinologic and Metabolic Drugs Advisory Committee meeting reached a decision regarding the New Drug Application, by The Bristol-Myers Squibb Company and AstraZeneca for the investigational compound dapagliflozin for treatment of type 2 diabetes...

New Investigational Drug Improved HbA1c in Adults with Type 2 Diabetes

Bristol-Myers Squibb Company and AstraZeneca announced results from a randomized, double blind Phase 3 clinical study, which demonstrated that the addition of the investigational drug dapagliflozin to existing glimepiride (sulphonylurea) therapy produced significant reductions in HbA1c in adult patients with type 2 diabetes compared to glimepiride alone...

Bristol-Myers Squibbs’ Dapagliflozin Demonstrated Improved Glycemic Control in Adults with Type 2 Diabetes

Bristol-Myers announced that findings from a 24-week Phase 3 clinical study, published online in the latest issue of Diabetes Care, demonstrated that the investigational drug dapagliflozin, administered as a monotherapy, achieved statistically significant mean reductions at 5 mg and 10 mg doses once daily in the primary endpoint of HbA1c levels...

Sirona Biochem Corp. Says New Results Show SGLT2 Sugar Blockers Could Help Fight Diabetes

In a press release dated November 17, Sirona Biochem Corp. announced that results of their latest clinical trials showed the SGLT2 inhibitor dapagliflozin lowered levels of HbA1c blood sugar significantly more than the placebo, and that it was safe and well tolerated with no serious treatment-related adverse events...