Zealand Pharma today announced the approval of lixisenatide by the
U.S. Food and Drug Administration (FDA).
Under the brand name Aslyxin, lixisenatide is approved for use in combination with diet and exercise to treat Type 2 diabetes. It can also be combined with oral diabetes medications and basal insulin. Zealand has licensed the development and commercial rights for lixisenatide to Sanofi.
"Today is an important day for Zealand," President and CEO Britt Meelby Jensen said. "With the FDA approval of Adlyxin we have successfully passed the final regulatory milestone for the first Zealand invented product to become available for diabetes patients in the significant U.S. market. We look forward to Sanofi’s launch of Adlyxin, while awaiting the FDA’s regulatory decision on iGlarLixi, the single product combination of Adlyxin and Lantus, expected in August 2016.”
With Type 2 diabetes, the body develops an insulin resistance and eventually the pancreas is unable produce enough insulin to maintain blood sugar levels. Excess blood sugar can negatively affect the eyes, heart, kidneys and nervous system. Treatment includes diet, exercise, insulin and other medications. Approximately 27.5 million Americans suffer from Type 2 diabetes.
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