Friday, June 28, 2013

Lyxumia approved in Japan for the treatment of type 2 diabetes

Sanofi and Zealand pharma announced that its once daily GLP-1 agonist  Lyxumia®  has been approved Japan.  It is the first GLP-1 to be approved for use in combination with basal insulin. The rationale behind combining basal insulin with Lyxumia, is that the two drugs when combined can help effectively control both post prandial glucose (PPG) and fasting plasma glucose (FPG).
Basal insulin, in general has a more profound impact on fasting plasma glucose (FPG), and not on the post prandial glucose (PPG).  Hence over time patients treated wtih basal insulin may no longer stay on their HbA1C goal, which is a function of both FPG and PPG control. Hence it is required that it is important that a medication be added which can target the PPG. Compared to other GLP-1's on the market (Liraglutide and Exenatide), Lyxumia can give much better control of the post prandial glucose. Hence a combining a basal insulin with Lyxumia would be a very effective strategy to attain HbA1C control, weight management and lower the risk of hypoglycemia.
Lyxumia® is now approved in the European Union, Japan, Australia and Mexico. In the United States, the New Drug Application (NDA) submitted for the product to the Food and Drug Administration (FDA) by Sanofi is currently being reviewed.
Under the license agreement with Sanofi, Zealand is entitled to tiered low double-digit percentage royalties on world-wide sales of Lyxumia®

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