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Lilly plans Q1 2027 filing for obesity triple retatrutide
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pharmaphorum
Armed with new pivotal trial results, Eli Lilly plans to file for approval of its keenly anticipated new weight-loss therapy, retatrutide, in the US in the first quarter of next year.
The drugmaker has released top-line data from the TRIUMPH-2 and TRIUMPH-3 studies, which together with its earlier TRIUMPH-1 and TRIUMPH-4 trials, will form the basis of a broad marketing application to the FDA for obesity.
Lilly is currently completing the comprehensive chemistry, manufacturing, and controls (CMC) data package required for a Biologics License Application (BLA).
Analysts at Clarivate have concurred, suggesting $30 billion-plus revenues are possible with the triple agonist, and predicting it will become the primary growth driver in the obesity drug market after 2028.
Meanwhile, Lilly has also reported impressive data in type 2 diabetes patients in the TRANSCEND-T2D-1 trial.