Avandamet sNDA Approved For First-Line Use In Type 2 Diabetics
This article was originally published in The Pink Sheet Daily
Executive Summary
GlaxoSmithKline’s updated label for the rosiglitazone/metformin combination also includes new data concerning risk in congestive heart failure patients.
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GlaxoSmithKline's Avandamet was approved by FDA for first-line use in patients with type 2 diabetes May 19. The Indications section of the revised label reads, "Avandamet is indicated as an adjunct to diet and exercise to improve glycemic control in patients with type 2 diabetes mellitus when treatment with dual rosiglitazone and metformin therapy is appropriate." Avandamet (rosiglitazone/metformin) was previously approved for patients already treated with combination rosiglitazone and metformin or for those who were not adequately controlled on metformin alone. Prior labeling noted that the safety and efficacy of Avandamet had not been established as initial pharmacologic therapy. However, clinical trial data has been added to the new label demonstrating the safety and efficacy of Avandamet in drug-naive patients. In a 32-week randomized, double-blind clinical trial, 468 drug-naive patients with type 2 diabetes were randomized to receive Avandamet, rosiglitazone or metformin. Patients treated with Avandamet demonstrated a statistically significant improvement in Fasting Plasma Glucose and HbA1c levels, labeling says. In addition, updated labeling incorporates new data concerning congestive heart failure. The drug already carried a warning for cardiac failure, but the revised label includes data showing that patients with New York Heart Association Class I and II CHF who were treated with rosiglitazone have an increased risk of CV events. GSK submitted the sNDA for Avandamet last June. In April, GSK issued an update on the supply status of Avandia (rosiglitazone) and Avandamet, saying it anticipated Avandia levels would be restored shortly, ahead of Avandamet (1 (Also see "GSK Expects To Restore Avandia Inventory Before Avandamet" - Pink Sheet, 4 May, 2006.)). Supplies of both drugs, along with Paxil CR (paroxetine extended-release) and Coreg (carvedilol), faced a shortage starting at the end of 2005 after new product release documentation procedures were implemented at GSK's Cidra, Puerto Rico manufacturing facility (2 (Also see "GSK Urges Conservation Of Coreg, Citing Limited Availability" - Pink Sheet, 11 Jan, 2006.)). - Jessica Merrill |