Patients using farxiga typically reduce their a1c by an. Type 2 diabetes drug dapagliflozin rejected by fda. Food and drug administration fda is warning that the type 2 diabetes medicines canagliflozin, dapagliflozin, and empagliflozin may lead to ketoacidosis, a serious condition where the body produces high levels of blood acids called ketones that may require hospitalization. Administration with a highfat meal decreased peak plasma concentration by up to 50% and prolonged time to peak plasma concentration by approximately 1 hour. Pdf efficacy and safety of dapagliflozin in patients. Reviewed by judith stewart bpharm last updated on may 6, 2020. Farxiga dapagliflozin tablets, for oral use initial u. Nov 16, 2011 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. Dapagliflozin propanediol pharmacokinetics absorption bioavailability. Fda rejects dapagliflozin for type 2 diabetes medpage today.
At a july 2011 advisory committee meeting to discuss dapagliflozin, the panel had voted 96 against recommending approval, primarily as a result of concerns about. The committee will discuss supplemental new drug application snda 204629. The effect of dapagliflozin is an increased glucosuria, and it was shown that mean blood glucose concentrations and postprandial glucose excursion in special were significantly reduced in type 2 diabetic patients. Metaanalysis of clinical data on cardiovascular safety. Fda approves dapagliflozin to cut risk of hospitalization. Fda approves oncedaily qtern dapagliflozin and saxagliptin. Fda warns that sglt2 inhibitors for diabetes may result in. Similarly, as addon to pioglitazone, dapagliflozin provided sustained glycaemic control compared with placebo over 48 weeks of treatment difference.
Addendum to fda briefing document advisory committee meeting december 12 20 for dapagliflozin. Serious hypersensitivity to dapagliflozin eg, anaphylaxis, angioedema patients who are being treated for glycemic control without established cvd or multiple cv risk factors with severe renal impairment egfr 30 mlmin1. The food and drug administration has approved the entry of dapagliflozin, a drug for treating type 2 diabetes, into the u. The drug is called forxiga in europe, where it has been approved since november 2012. Dapagliflozin causes intravascular volume contraction. Dapagliflozin is used with a proper diet and exercise program to control high blood sugar in people with type 2 diabetes. 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 is currently approved under the trade name forxigatm for the treatment of adults with type 2 diabetes, along with diet and exercise, in 38 countries, including the european union and australia. 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 inhibitor of. Patients at risk include those with dehydration or reduced volume status, particularly in patients with impaired renal function egfr less than 60 mlminute1.
Jan 19, 2012 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 inhibitor of. Dapagliflozin is a small molecule drug for reducing blood glucose and treating type2 diabetes mellitus. Dapagliflozin was rejected by the fda in january 2012 because of concerns about its riskbenefit profile. Product information for auspar xigduo xr dapagliflozin as propanediol monohydrate metformin hydrochloride astrazeneca pty ltd pm20151515 date of finalisation 17 december 2014. Patients currently receiving dapagliflozin in a dual therapy regimen that is not recommended according to the above criteria should have the option to continue treatment until they and their clinician consider it. Update on longterm efficacy and safety of dapagliflozin.
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 is a sodiumglucose cotransporter 2 inhibitor indicated for managing diabetes mellitus type 2. A dedicated randomized, placebocontrolled trial of dapagliflozin in patients with chronic kidney disease mainly stage 3, with an egfr. Fda briefing document endocrine and metabolic drug. Take dapagliflozin at around the same time every day. Food and drug administrations fda endocrinologic and metabolic drugs advisory committee meeting reached a decision regarding the new drug application, by the bristolmyers squibb company and astrazeneca for the investigational compound dapagliflozin for treatment of type 2 diabetes. Dapagliflozin is 78% bioavailable and rapidly absorbed. Advisory committee meeting december 12 december 6, 20. Type 2 diabetes drug dapagliflozin rejected by fda advisory. Listing a study does not mean it has been evaluated by the u. Forxiga 5 mg film coated tablets summary of product.
See the end of this medication guide for a list of ingredients in farxiga. Fda oks dapagliflozin as type 2 drug diabetes health. Canagliflozin, dapagliflozin warnings strengthened by fda. Call your doctor for medical advice about side effects. Fda approves the sglt2 inhibitor farxiga dapagliflozin.
Jul 20, 2011 diabetes drug dapagliflozin rejected by f. The fda has approved dapagliflozin for the treatment of adults with type 2 diabetes, as an adjunct to diet and exercise, to improve glycemic control. Pdf efficacy and safety of dapagliflozin in patients with. This product information was approved at the time this auspar was published. Dapagliflozin dosed directly to juvenile rats from postnatal day pnd 21 until pnd 90 at doses of 1, 15, or 75 mgkgday, increased kidney weights and increased the incidence of renal pelvic and tubular dilatations at all doses. Fda strengthens sglt2 kidney risk warnings medpage today. Study with dapagliflozin gloria the safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Dapagliflozin propanediol monograph for professionals. Dapagliflozin, manufactured by bristolmyers squibb and astrazeneca, will be sold under the brand name farxiga.
Fda strengthens kidney warnings for diabetes medicines canagliflozin invokana, invokamet and dapagliflozin farxiga, xigduo xr share tweet. It is taken usually with or without food once a day in the morning. Controlling high blood sugar helps prevent kidney damage, blindness, nerve. Farxiga dapagliflozin is a sodiumglucose cotransporter 2 sglt2 inhibitor indicated for the treatment of type 2 diabetes mellitus and heart failure. Follow the directions on your prescription label carefully, and ask your doctor or pharmacist to explain any part you do not understand. Dapagliflozin, an investigational compound in the u. It is used in certain people to lower the risk of having to go to the hospital for heart failure. Dapagliflozin, bms512148 2s,3r,4r,5s,6r24chloro34ethoxybenzylphenyl6hydroxymethyltetrahydro2hpyran3,4,5triol, cas 461432268 molecular formula. You may report side effects to fda at 1800 fda 1088. Update on longterm efficacy and safety of dapagliflozin in. A federal advisory committee voted 9 to 6 on tuesday that a firstofitskind diabetes drug should not be. The fda is strengthening a warning on the labels of two diabetes drugs to reflect risk of acute kidney injuries. Qtern dapagliflozin and saxagliptin tablets, for oral use. Health professional information summary product information route of administration dosage form strength clinically relevant nonmedicinal ingredients oral tablet 5 mg, 10 mg lactose for a complete listing see dosage forms, composition and packaging section.
Statement on a nonproprietory name adopted by the usan council efficacy and safety of dapagliflozin, added to therapy of patients with type 2 diabetes with inadequate glycemic control on insulin, clinicaltrials. The drug helps to support weight loss but may raise the risk of genital thrush and urinary tract infections. At a july 2011 advisory committee meeting to discuss dapagliflozin, the panel had voted 96 against recommending approval, primarily as a result of concerns about potential associations with breast and bladder cancer. Fda approved indications dapagliflozin is indicated as an adjunct to diet and exercise to improve glycemic control in patients with t2dm. Symptomatic hypotension can occur after initiating dapagliflozin. When combined with diet and exercise in adults, dapagliflozin helps to improve glycemic control by inhibiting glucose resorption in the proximal tubule of the nephron and causing glycosuria. Dapagliflozin in combination with insulin alone or with other antidiabetic drugs is an option for the treatment of type. Dapagliflozin resubmitted to fda diabetes in control. Farxiga dapagliflozin dose, indications, adverse effects. When untreated, type 2 diabetes can lead to serious problems, including blindness, nerve and kidney damage, and heart disease.
Nov 18, 2019 dapagliflozin 3oglucuronide, inactive metabolite of dapagliflozin, is a substrate of organic anion transport oat 3. Farxiga dapagliflozin dosing, indications, interactions. Bristolmyers squibb application no 202293 approval date. The us food and drug administration fda has approved empagliflozin jardiance, boehringer ingelheim pharmaceuticals inc for the new indication of improving survival in adults with type 2. For patients not already taking dapagliflozin, the recommended starting dose for dapagliflozin is 5 mg once daily. Efficacy and safety of dapagliflozin in patients with type 2 diabetes and moderate renal impairment chronic kidney dis ease stage 3a. In a prespecified analysis of subjects with baseline hba1c. The us food and drug administration fda has approved empagliflozin jardiance, boehringer ingelheim pharmaceuticals inc for the new indication of improving survival in. Dapagliflozin was associated with a statistically significant reduction in the calculated mean daily insulin dose. Dapagliflozin in combination therapy for treating type2. Dapagliflozin in combination with insulin alone or with other antidiabetic drugs is an option for the treatment of type 2 diabetes. Exposure at the lowest dose was 15times the 10 mg clinical dose, based on auc.
Persons with disabilities having problems accessing the pdf files below may call 301 7963634 for assistance. Medicines in the sglt2 inhibitor class include canagliflozin, dapagliflozin, and empagliflozin see section on list of fdaapproved sglt2 inhibitors for type 2 diabetes. Fda briefing document endocrine and metabolic drug advisory. Due to its mechanismof action it seems likely that also type 1. It is used to lower blood sugar in patients with high blood sugar diabetes. Forxiga dapagliflozin functio, suitability, side effects. The drug belongs to a new class of type 2 medications called sglt2 sodium glucose cotransporter 2 inhibitors that block the reabsorption of glucose. For patients already treated with background metformin use of dapagliflozin, reduced hba 1c compared with glipizide mean difference.
Fda has granted dapagliflozin fast track designation for an indication of reducing the risk of cardiovascular death for patients with heart failure with reduced ejection fraction or preserved. On january 8, the fda approved farxiga dapaglifozin for the treatment of type 2 diabetes. Food and drug administration 10903 new hampshire avenue silver spring, md 20993 1888info fda 18884636332 contact fda. Farxiga dapagliflozin is a sodiumglucose cotransporter 2 sglt2 inhibitor indicated. 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 added to dapagliflozin in adult patients with type2 diabetes who experienced inadequate glycemic control hba1c. Study with dapagliflozin full text view clinicaltrials. Fda approves the sglt2 inhibitor farxiga dapagliflozin for. New labels for the two sodiumglucose transport 2 sglt2 drugs canagliflozin. Jun 14, 2016 the fda is strengthening a warning on the labels of two diabetes drugs to reflect risk of acute kidney injuries. Fda approves farxiga dapagliflozin tablets for the. Because forxiga is a relatively new medication, the long term effects of the drug, over several years, are as yet unknown. Chairman and members of the endocrinologic and metabolic drugs advisory committee. Endocrine and metabolic drug advisory committee meeting.
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