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.
Tag: AstraZeneca
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.
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...
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...
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 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...
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 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...