The U.S. FDA has lifted certain restrictions on prescribing and use of the diabetes drug Avandia (rosiglitazone) to reflect new information regarding the cardiovascular risk of the medicine. Read more
Results showed a reduction in HbA1c of 0.78% for patients receiving albiglutide compared to a reduction of 0.99% for liraglutide. While albiglutide did demonstrate a statistically significant reduction in HbA1c from baseline (p<0.001), it did not meet the pre-specified primary endpoint of non-inferiority to liraglutide... Read more
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… Read more
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… Read more
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… Read more
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… Read more
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… Read more
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… Read more
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… Read more
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… Read more