The U.S. Food and Drug Administration granted fast track status for the development of AstraZeneca’s diabetes drug Farxiga to prevent heart and kidney failure in patients with chronic kidney disease.
Shares of Texas-based Lexicon Pharmaceuticals shot up after the company announced positive 52-week cardiorenal data from a pooled analysis of the type 1 diabetes trials Tandem1 and Tandem2.
Janssen’s Invokana became the only medicine in nearly 20 years and the first diabetes medicine ever to demonstrate a reduction in progression to end-stage renal failure in T2D patients with CKD.
The largest clinical trial so far to assess a new class of diabetes pills shows that AstraZeneca’s Farxiga can prevent heart failure and cut the risk of kidney problems in a broad range of patients.
The U.S. FDA said a serious genital infection was reported in patients taking a certain class of diabetes drugs, with one death and 11 others hospitalized.
Janssen Pharmaceuticals halted the company’s Phase III chronic kidney disease trial for Invokana early due to the fact that the SGLT2 diabetes drug had already achieved pre-specified efficacy data.
A European Medicines Agency (EMA) panel recommended granting marketing approval to the diabetes drug Steglatro developed by Merck & Co. Inc. and Pfizer Inc.
The U.S. FDA approved Merck’s and Pfizer’s Steglatro (ertugliflozin), a sodium-glucose co-transporter 2 (SGLT2)- inhibitor, which will square off against established drugs in the market.
Seniors with type 2 diabetes or those with diabetic complications were less likely to be hospitalized for heart failure while taking a sodium-glucose co-transporter 2 (SGLT2) inhibitor compared to dipeptidyl peptidase-4 (DPP4) inhibitors, another new class of oral antidiabetic drug, according to a study released in Cardiovascular Diabetology and conducted by Anthem Inc. and HealthCore.
Lexicon Pharmaceuticals Inc. announced additional positive data from the pivotal Phase 3 inTandem2 study of sotagliflozin, an investigational dual SGLT1 and SGLT2 inhibitor.