INDIANAPOLIS (dpa-AFX) - Thursday, Eli Lilly and Company (LLY) announced that the U.S. Food and Drug Administration has approved Onswik, a once-weekly basal insulin injection, for treatment of adults living with type 2 diabetes.
Following approval, Onswik KwikPen will soon be available in the U.S. in two concentrations of 500 units/mL and 1000 units/mL.
The approval is based on data from the QWINT Phase 3 clinical trials, which evaluated the safety and efficacy of once-weekly Onswik in over 3,400 adults with type 2 diabetes.
In each trial, Onswik met the primary endpoint of non-inferior A1C reduction from baseline that was comparable to insulin glargine U-100 or insulin degludec U-100.
In pre-market hours, LLY was trading at $1,150.94, down 0.15 percent on the New York Stock Exchange.
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