Eli Lilly’s Tirzepatide Receives the US FDA’s Fast Track Designation for the Treatment of Obesity
Shots:
- The US FDA has granted FTD to tirzepatide for obesity, or overweight with weight-related comorbidities. The P-III (SURMOUNT-1) trial evaluates tirzepatide (5/10/15mg) vs PBO in a ratio (1:1:1:1) in 2539 adult patients without T2D across the US, Argentina, Brazil, China, India & other countries
- The co-primary objectives of the study showed that tirzepatide (10/15mg) was superior in the percentage of body weight reductions from baseline and patients achieved ≥5% body weight reduction @72wk. The P-III (SURMOUNT-2) are expected to complete at the end of April 2023
- The company plans to initiate a rolling submission of NDA for tirzepatide for obesity or overweight in 2022, based on 2 P-III (SURMOUNT-1 & 2) trial results
Ref: PRNewswire | Image: Eli Lilly
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