The FDA has requested clinical trial data from the manufacturer of saxagliptin, Bristol-Myers Squibb and AstraZeneca, to investigate a possible association between use of the type 2 diabetes drug and heart failure.
Tag: Onglyza
AstraZeneca and Bristol-Myers Squibb have announced the full results of the SAVOR clinical trial of Onglyza (saxagliptin) in 16,492 adult patients with type 2 diabetes at high risk for cardiovascular events.
The FDA is evaluating unpublished new findings by a group of academic researchers that suggest an increased risk of pancreatitis, or inflammation of the pancreas, and pre-cancerous cellular changes called pancreatic duct metaplasia in patients with type 2 diabetes treated with a class of drugs called incretin mimetics.
The European Commission has approved Bristol-Myers Squibb Company and AstraZeneca's ONGLYZA (saxagliptin) for use as a combination therapy with insulin (with or without metformin) to improve blood sugar (glycemic) control in adult patients with type 2 diabetes...
Results of an investigational Phase 3b clinical study, presented by Bristol-Myers Squibb Company and AstraZeneca at the 47th European Association for the Study of Diabetes (EASD), have shown that adding ONGLYZA (saxagliptin) 5 mg to ongoing insulin therapy (with or without metformin) maintained reductions of blood sugar levels (glycosylated hemoglobin levels, or HbA1c) in adult patients with type 2 diabetes...
The European Commission approved a label update for ONGLYZA® (saxagliptin) in the treatment of adults with type 2 diabetes who have moderate or severe renal impairment following results of a new study submitted by AstraZeneca and Bristol-Myers Squibb Company. The approved dosage for the patient group is a new once-daily 2.5 mg dose...
Bristol-Myers Squibb Company and AstraZeneca announced that type 2 diabetes drug Kombiglyze XR (saxagliptin and metformin HCl extended-release), approved by the FDA on November 5, 2010, is now available by prescription in pharmacies across the United States. Kombiglyze XR is the first and only once-a-day metformin extended-release (XR) plus dipeptidyl peptidase-4 (DPP-4) inhibitor combination tablet offering strong glycemic...
Bristol-Myers Squibb Company and AstraZeneca announced FDA approval of KOMBIGLYZE™ XR, the first and only once-a-day metformin extended-release (XR) plus dipeptidyl peptidase-4 (DPP-4) inhibitor combination tablet for the treatment of type 2 diabetes in adults. KOMBIGLYZE XR offers...