Eli Lilly plans to complete its application for FDA approval of tirzepatide in the coming weeks and expects regulatory action as early as later this year.
Eli Lilly plans to complete its application for Food and Drug Administration approval of the drug in the coming weeks and expects regulatory action as early as later this year. The FDAThe approval would open "up the opportunity for many more people to benefit from tirzepatide," Eli Lilly CEO David Ricks said Thursday on CNBC's "Squawk Box." He added that the drug sets a "new bar for weight loss and people with diabetes.
The data come as companies try to capitalize on increased consumer demand for weight-loss treatments. Some experts have criticized the increased use of the drugs as a potentially damaging extension of diet culture. The phase three trial followed 938 adults who were overweight and had type 2 diabetes. Patients who took a 10 milligram version of the injection after 72 weeks lost nearly 30 pounds on average, while those who took 15 milligrams lost 34 pounds on average.About 86% of patients in the trial who took tirzepatide lost at least 5% of their body weight, compared to about 30% in the placebo group
The level of average weight loss seen in the trial "has not been previously achieved in phase 3 trials for obesity or overweight and type 2 diabetes," Jeff Emmick, Eli Lilly's senior vice president of product development, said in a statement., which measures the body's average blood sugar level over the past three months. Higher levels of A1C are associated with a higher risk of diabetes complications.
Eli Lilly said it will continue to monitor results from the trial. The company will present the findings at aRead CNBC's latest global health coverage:
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