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FDA Approves Rapid-Acting Insulin

By D. Lawson Allen on July 2, 2020
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The FDA approved Eli Lilly’s Lyumjev™ (insulin lispro-aabc injection, 100 units/mL and 200 units/mL) last month, which is a new rapid-acting insulin indicated to improve glycemic control in adults with type 1 and type 2 diabetes.  The approval was based on two phase 3 clinical trials based on comparison of Lyumjev and Humalog (insulin lispro injection, 100 units/mL).  Lyumjev demonstrated superior reduction in blood glucose spikes at both one hour and two hours after a test meal as compared to Humalog.  The interactive Multichannel News Release can be found here.

This the second insulin product approved by the FDA in June.

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  • Posted in:
    Health Care and Life Sciences
  • Blog:
    Biosimilars Law Bulletin
  • Organization:
    Rothwell Figg
  • Article: View Original Source

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