Lilly seeks rapid FDA approval for oral GLP-1 orforglipron after positive obesity “switching” study
Eli Lilly has submitted its once‑daily oral GLP‑1 receptor agonist orforglipron to the US FDA for approval in obesity.13
The FDA has granted orforglipron a new “national priority” review voucher, shortening review to a decision expected within weeks instead of the usual 6–10 months.3
Orforglipron is a non‑peptide, small‑molecule oral GLP‑1 that can be taken once daily without restrictions on food or water intake.2
In the Phase 3 ATTAIN‑MAINTAIN trial, orforglipron helped patients maintain weight loss after switching from injectable GLP‑1/GIP drugs such as Zepbound (tirzepatide) or Wegovy (semaglutide).234
Participants had previously completed a 72‑week course of Zepbound or Wegovy injections before entering the oral maintenance study with orforglipron.3
People switching from Wegovy to orforglipron gained less than 1 kg over one year, versus about 5 kg regain in those who continued Zepbound; placebo patients regained more than 9 kg before being offered rescue orforglipron.3
ATTAIN‑MAINTAIN met its primary and all key secondary endpoints, with orforglipron showing superior weight maintenance vs. placebo as an adjunct to diet and physical activity.24
The positive switching/maintenance data support Lilly’s plan to position orforglipron as a long‑term oral maintenance option in the chronic management of obesity following injectable incretin therapy.23
Lilly’s broader Phase 3 program (ATTAIN and ACHIEVE trials) previously showed that orforglipron induces meaningful weight loss and cardiometabolic improvements, underpinning its global regulatory submissions for obesity starting in 2025.1
Orforglipron is not yet FDA‑approved for any indication; it remains investigational until the FDA completes its expedited review.13
Sources:
1. https://www.lilly.com/news/stories/what-to-know-about-orforglipron
2. https://www.pharmexec.com/view/eli-lilly-announces-topline-results-phase-iii-trial-studying-oral-glp-therapy-orforglipron
3. https://www.biopharmadive.com/news/eli-lilly-orforglipron-maintenance-study-national-priority-voucher-fda/808250/
4. https://www.hcplive.com/view/orforglipron-maintains-weight-loss-in-patients-switching-from-semaglutide-or-tirzepatide