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That search behaviour does not change the regulatory difference between the two, but it does explain why the comparison is now more common
What the FDA Requires in the BLA Efficacy Data: TRIUMPH-4: 28.7% weight loss Complete TRIUMPH-1: 28.3% weight loss Complete TRIUMPH-2: 20.8% weight loss (obesity + diabetes) Complete TRIUMPH-3: 22.6% weight loss (obesity + cardiovascular disease) Complete, MACE data not statistically significant Safety Data: Side effect profile across all four populations Short-term and medium-term adverse events, including the dysesthesia signal (up to 20.9% at 12mg) Drug interactions, especially with diabetes medications Manufacturing Data: Scale-up capability for millions of doses per month Quality control and stability data Cold chain distribution logistics Realistic Approval Scenarios With the BLA filing point now expected (Q1 2027), the remaining uncertainty is largely in the FDA review itself not in whether or when Lilly files
Lipid improvements typically become apparent within 12-20 weeks of initiating therapy, paralleling weight loss trajectory
However, in some cases, off-label use is acceptable, especially in therapeutic areas with few treatment alternatives [42]
