Eli Lilly CFO Lucas Montarce confirmed the company's timeline for its oral obesity drug, orforglipron, at the JPMorgan Healthcare Conference. Lilly targets potential FDA approval for the treatment in the second quarter of 2026.
Lilly has submitted its regulatory application for orforglipron. The company is utilizing a National Priority Voucher (NPV) to accelerate the process. The NPV is expected to significantly shorten the standard 10-to-12-month FDA review timeline.
This timeline positions orforglipron to enter the highly competitive and lucrative market for oral weight-loss treatments. The drug will compete directly with Novo Nordisk’s recently approved Wegovy pill.
The announcement reinforces Lilly’s strategy to build a leading franchise in metabolic diseases. Lilly previously expressed confidence in its ability to supply the market immediately upon the anticipated launch.