GlaxoSmithKline (GSK) announced that the results from the first of eight Phase III studies of type 2 diabetes drug, albiglutide, have been received. The study, known as Harmony 7, is a head-to-head study designed to compare albiglutide, an investigational once weekly glucagon-like peptide-1 (GLP-1) agonist, to once-a-day liraglutide, an approved treatment for type 2 diabetes, in the same class. The primary endpoint of the study was reduction in HbA1c, a marker of the amount of glucose in the blood. Results showed a reduction in...

Following an ongoing FDA review of  the diabetes drug Avandia (rosiglitazone) the FDA will require that GlaxoSmithKline (GSK) develop a restricted access program for Avandia under a risk evaluation and mitigation strategy, or REMS. Under the REMS, Avandia will be available to new patients only if they are unable to achieve glucose control on other medications and are unable to take Actos (pioglitazone), the only other drug in this class. Current users of Avandia who are benefiting from the drug will be able to continue using...

The continuing controversy surrounding the cardiovascular risk of GlaxoSmithKline’s diabetes drug Avandia has led to sharp declines in its use and a surge in sales of the competing drug, Actos. Although the drugs are similar and both had FDA warnings in 2007, Takeda’s Actos has been perceived to be safer for the treatment of type 2 diabetes. Avandia (Rosiglitazone) and Actos (pioglitazone) belong to the same class of drugs, called TZDs or thiazolidinediones. They help the body use insulin more effectively by boosting...

GlaxoSmithKline confirmed today that it will suspend enrollment of new patients in the Thiazolidinedione Intervention with Vitamin D Evaluation (TIDE) clinical trial at the request of the U.S. Food and Drug Administration (FDA) pending FDA  review of recommendations from its  Advisory Committee meeting July 13-14. Patients already enrolled may continue in the trial. This post-marketing study is designed to examine the comparative cardiovascular safety of rosiglitazone (Avandia) and pioglitazone (Actos) in patients with type...

GlaxoSmithKline confirmed that a joint advisory committee to the U.S. Food and Drug Administration (FDA) voted to allow the diabetes drug Avandia to remain on the market. Committee members voted for recommendations ranging from making no changes to the current label, to revising the label with additional warnings and restrictions (20) to withdrawal from the U.S. market (12). The recommendation of the Endocrinologic and Metabolic Drugs Advisory Committee and the Drug Safety and Risk Management Advisory Committee will now be considered...

According to a new report published in the Lancet, taking a low dose of GlaxoSmithKline’s diabetes drug Avandia (rosiglitazone) combined with metformin was highly effective in prevention of type 2 diabetes in patients with impaired glucose tolerance, with little effect on the clinically relevant adverse events of these two drugs. The study included 207 patients with impaired glucose tolerance who were randomly assigned to receive combination rosiglitazone (2 mg) and metformin (500 mg) twice daily or matching placebo...

GlaxoSmithKline Plc has settled thousands more lawsuits brought by patients alleging its Avandia diabetes drug caused heart attacks, in a move that may defuse potentially massive claims over the medicine. According to a Reuters report, a spokeswoman for Glaxo said that consolidated cases which had been due to come to court in Philadelphia this month had been settled. This settlement follows a separate settlement of some 700 cases last month for about $60 million.

GlaxoSmithKline Plc agreed to pay about $60 million in the first settlements of lawsuits alleging the company’s Avandia diabetes drug causes heart attacks and strokes in some users, according to a Bloomberg report. Glaxo agreed to resolve more than 700 Avandia suits filed by three attorneys, including Houston-based plaintiffs’ lawyer Mark Lanier and Philadelphia-based litigator Sol Weiss. The settlements come as Glaxo is set to face its first Avandia trial in state court in Philadelphia in July. The company faces about...

The Food and Drug Administration (FDA) is considering stopping a safety study involving thousands of patients taking GlaxoSmithKline PLC’s Avandia according to the Wall Street Journal. Avandia has been linked to an increased risk of heart attack. If the trial is stopped, the FDA will also consider asking Glaxo to stop selling the drug, a decision that could also determine whether the drug stays on the U.S. market. No decision on the trial (called TIDE) has been made yet, and according to the WSJ won’t be until after...

Senator Herb Kohl (D), chair of the Special Committee on Aging, sent letters to AstraZeneca, GlaxoSmithKline, Eli Lilly, Novartis, Pfizer, and Sanofi-Aventis asking them to explain why Americans on average pay twice as much as people in other industrialized countries for prescription drugs, according to Reuters report. The letter comes at a time when the drug companies are under attack from some Democrats involved in health care reform. In response to the letter Eli Lilly said drug prices were lower in other countries for...