Amylin Pharmaceuticals has received FDA approval to market its first-in-class diabetes therapy Symlin, to be used in conjunction with insulin to treat type 1 or 2 diabetes.
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Symlin (pramlintide acetate) injection will be used at mealtime in patients with type 2 or type 1 diabetes who have failed to achieve desired glucose control despite optimal insulin therapy.
Clinical studies demonstrate that Symlin, a self-administered injection given prior to meals, helps patients achieve lower blood glucose after meals, leading to less fluctuation during the day, and better long-term glucose control compared to patients taking insulin alone.
“Symlin provides a new option for many patients who, despite their best efforts with insulin therapy, continue to struggle to achieve their glucose control targets,” said Dr Robert Ratner, an investigator for Symlin clinical studies, vice president for scientific affairs at MedStar Research Institute and professor of medicine at the Georgetown University Medical School. “The science behind Symlin has improved our understanding of the physiology of diabetes and has provided a welcome new tool for insulin users.”
“The approval of Symlin, a first-in-class therapy, is a major milestone for Amylin Pharmaceuticals,” added Ginger Graham, president and CEO of Amylin. “It is the result of 18 years of research in diabetes.”