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Amylin Pharmaceuticals is seeking approval from the Food and Drug Administration (FDA) for its once-weekly injectable diabetes treatment.
The biotechnology company’s exenatide LAR is a new version of the twice-daily injectable drug Byetta, which is used to control blood sugar levels.
According to Wall Street, getting approval for the highly anticipated drug has the potential to reinvigorate sales for Amylin, and the drug is seen as commercially advantageous because it requires a much lower dose than previous treatments.
Competition for exenatide LAR includes Novo Nordisk’s once-daily injection liraglutide, which is currently under FDA review.
Both exenatide LAR and liraglutide help increase the body’s insulin production and are part of the GLP-1 analogues class of diabetes treatments.
Companies developing diabetes treatments must follow new safety guidelines issued by the FDA, which came into force after concerns about heightened risks of heart attack with GlaxoSmithKline’s blockbuster pill Avandia.
Copyright Press Association 2009
