Because forxiga is a relatively new medication, the long term effects of the drug, over several years. Product information for auspar xigduo xr dapagliflozin as propanediol monohydrate metformin hydrochloride astrazeneca pty ltd pm20151515 date of finalisation 17 december. Chairman and members of the endocrinologic and metabolic. Dapagliflozin is dosed starting at 5 mg orally in the morning and can be titrated up to 10 mg orally in the morning if clinically indicated. Dapagliflozin side effects, dosage, interactions drugs. The fda approved qtern based on data from a 24week, phase iii, multicenter, randomized, doubleblind, placebocontrolled trial n315 designed to evaluate the efficacy and safety of saxagliptin.
Dapagliflozin is part of a new class of drugs that work in the kidney to block a protein. The drug helps to support weight loss but may raise the risk of genital thrush and urinary tract infections. Dapagliflozin is an oral diabetes medicine that helps control blood sugar levels. Food and drug administrations fda endocrinologic and metabolic drugs advisory committee meeting reached a decision regarding the new drug application, by the bristolmyers squibb. Dapagliflozin and measures of cardiovascular autonomic. Metaanalysis of clinical data on cardiovascular safety. Fda strengthens kidney warnings for diabetes medicines canagliflozin invokana, invokamet and dapagliflozin farxiga, xigduo xr. Endocrine and metabolic drug advisory committee meeting. Dapagliflozin works by helping the kidneys get rid of glucose from your bloodstream.
Fda rejects dapagliflozin for type 2 diabetes medpage today. Reviewed by judith stewart bpharm last updated on may 6, 2020 fda approved. Forxiga 5 mg film coated tablets summary of product. Fda finally oks dapagliflozinsaxagliptin for type 2 diabetes. It is a selective and reversible inhibitor of the sodiumglucose cotransporter 2 sglt2, which is selectively expressed in the kidney. Dapagliflozin is a prescription medication used to control blood sugar levels in people with type 2 diabetes.
Dapagliflozin side effects, uses, dosage, overdose. Exenatide once weekly plus dapagliflozin once daily versus exenatide or dapagliflozin alone in patients with type 2 diabetes inadequately controlled with metformin. After first rejecting it at the end of 2015, the fda has now approved the astrazeneca dpp4 inhibitorsglt2 inhibitor fixeddose combination product qtern for type 2 diabetes in adults. Advisory committee meeting december 12 december 6, 20. Farxiga dapagliflozin is indicated as an adjunct to diet and exercise to improve glycemic. Description dapagliflozin is a potent and selective hsglt2 inhibitor with ec50 of 1. Bristolmyers squibb application no 202293 approval date. Fda briefing document endocrine and metabolic drug. Controlling high blood sugar helps prevent kidney damage, blindness, nerve. Persons with disabilities having problems accessing the pdf files below may call 301 796. Dapagliflozin is 78% bioavailable and rapidly absorbed. Dapagliflozin added to saxagliptin plus metformin in type. The food and drug administration has approved the entry of dapagliflozin, a drug for treating type 2 diabetes, into the u. For patients requiring a dose of 5 mg dapagliflozin and 2000 mg metformin hcl extendedrelease, use two of the 2.
Type 2 diabetes drug dapagliflozin rejected by fda. The committee will discuss supplemental new drug application snda 204629. Indicated as an adjunct to diet and exercise to improve glycemic control with type 2 diabetes mellitus t2dm initial. Diabetes, type 2 farxiga dapagliflozin is a sodiumglucose cotransporter 2 sglt2 inhibitor indicated for the treatment of type 2 diabetes mellitus. Fda approved indications dapagliflozin is indicated as an adjunct to diet and exercise to improve glycemic control in patients with t2dm. An fda advisory committee recommended against approving the drug at a july meeting by a 96 vote, citing concern over potential breast and bladder cancer risks dapagliflozin is an. Australian public assessment report for dapagliflozin. Dapagliflozin causes intravascular volume contraction. Primary endpoint analyses by dapagliflozin dose were comparable to the overall results, with the relative risk of dapagliflozin compared to the control group as follows. There is a combination product dapagliflozinmetformin extendedrelease, called xigduo xr. Symptomatic hypotension can occur after initiating dapagliflozin. Dapagliflozin impurities synthink research chemicals. Dapagliflozin, manufactured by bristolmyers squibb and astrazeneca.
Dapagliflozin is a small molecule drug for reducing blood glucose and treating. May increase to 10 mg qday in patients tolerating 5 mgday who. Dapagliflozin propanediol monograph for professionals. At a july 2011 advisory committee meeting to discuss dapagliflozin, the panel had voted 96 against. On january 8, the fda approved farxiga dapaglifozin for the treatment of type 2 diabetes. Farxiga dapagliflozin dosing, indications, interactions. Reviewed by judith stewart bpharm last updated on may 6, 2020. Fda approves the sglt2 inhibitor farxiga dapagliflozin. Food and drug administration fda has strengthened the existing warning about the risk of acute kidney injury for the type 2 diabetes medicines canagliflozin invokana.
Pdf development and stability indicating hplc method for. Addendum to fda briefing document advisory committee meeting december 12 20 for dapagliflozin. Dapagliflozin has been studied as monotherapy or in. The us fda approved dapagliflozin in january 2014 to improve glycemic control along with diet and exercise in adult patients afflicted with t2dm. Dapagliflozin was rejected by the fda in january 2012 because of concerns about its riskbenefit profile. The objective of the study was to identify and quantify the dapagliflozin and its related impurities a, b, c, d, e, and f 5 table 1 in the marketed pharmaceutical. Farxiga dapagliflozin dose, indications, adverse effects. The fda has strengthened its drug label warnings about the risk for acute kidney injury in patients taking canagliflozin or dapagliflozin for type 2 diabetes. Dapagliflozin, an investigational compound in the u.
The drug is called forxiga in europe, where it has been approved since november 2012. Dapagliflozin resubmitted to fda diabetes in control. Dapagliflozin propanediol pharmacokinetics absorption bioavailability. Dapagliflozin is used with a proper diet and exercise program to control high blood sugar in people with type 2 diabetes. Fda approves farxiga dapagliflozin tablets for the. It has a potential to decrease glycated hemoglobin. Patients at risk include those with dehydration or reduced volume status. The investigators will compare the effect of dapagliflozin with an active comparator, glimepiride a different fda approved diabetes medication on measures of heart rate variability and. Randomized, doubleblind, phase 3 trial of triple therapy with dapagliflozin addon to saxagliptin plus metformin in type 2 diabetes. Food and drug administration 10903 new hampshire avenue silver spring, md 20993 1888info fda 18884636332 contact fda. Update on longterm efficacy and safety of dapagliflozin. Dapagliflozin is the first of a new class of drugs. Dapagliflozin is currently approved under the trade name forxigatm for the.