Avandia label updated to include cardiovascular risk warnings
The FDA is notifying the public that the labeling for Avandia (rosiglitazone tablets, from GlaxoSmithKline) has been updated to include information about associated cardiovascular risks.
Diabetes
Phase 3 study of lixisenatide for the treatment of type 2 diabetes mellitus (DM)
Zealand Pharma and sanofi-aventis announced that their Phase 3 study of lixisenatide achieved its primary endpoint of non-inferiority in HbA1c reduction from baseline in patients with type 2 diabetes mellitus (DM), compared with exenatide twice-daily.
FDA determines no cancer risk associated with Lantus
At this time, the FDA has concluded that Lantus (insulin glargine [recombinant], from sanofi-aventis) does not increase the risk of cancer.
FDA accepts NDA for extended-release Janumet for type 2 diabetes
Merck announced that the New Drug Application (NDA) for its investigational extended-release formulation of Janumet (sitagliptin/metformin HCI) for type 2 diabetes has been accepted for standard review by the FDA.
Phase 2b study of SB-509 for the treatment of diabetic neuropathy (DN)
Sangamo BioSciences announced that it has completed enrollment of its Phase 2b trial of SB-509 in patients with diabetic neuropathy (DN).
Kombiglyze XR available for type 2 diabetes
Bristol-Myers Squibb and AstraZeneca announced that Kombiglyze XR (saxagliptin and metformin HCl extended-release) is now available for the treatment of type 2 diabetes as an adjunct to diet and exercise when treatment with both saxagliptin and metformin is appropriate.
Phase 2 study of ETC-1002 for the treatment of dyslipidemia
Esperion Therapeutics announced that it has initiated a Phase 2 study for ETC-1002 for the treatment of patients with dyslipidemia.
Phase 2 Studies of CVBT-141B for Diabetic Wounds
CardioVascular BioTherapeutics (CVBT) announced data from its Phase 2 studies of CVBT-141B for the treatment of diabetic wounds.
Glumetza 500mg available again for type 2 diabetes
Santarus and Depomed announced that Glumetza (metformin HCl extended-release tablets) 500mg is available again.
Supplemental NDA submitted for Byetta for add-on therapy to insulin
Amylin Pharmaceuticals and Eli Lily announced that a supplemental New Drug Application (sNDA) has been submitted to the FDA for the expanded use of Byetta (exenatide) injection as an add-on therapy to basal insulin, with or without metformin and/or a thiazolidinedione (TZD) in conjunction with diet and exercise for adults with type 2 diabetes who are not achieving adequate glycemic control.
