In an interview with Bloomberg News, Eli Lilly Chief Financial Officer Lucas Montarce said that the Indiana-based pharma giant remains on track for a potential FDA approval of its obesity pill, orforglipron, in Q2 2026.
Montarce was responding to a question on whether Lilly (LLY) continues to expect a March approval of orforglipron after the FDA greenlighted Novo’s (NVO) Wegovy pill in December, giving the Danish company the first-mover advantage in the promising market for oral weight loss drugs.
In November, the FDA issued a National Priority Voucher for LLY’s GLP-1 receptor agonist, designed as a small molecule. The Trump administration introduced the National Priority Voucher program in June, targeting companies aligned with U.S. national interests to expedite the review timeline of their experimental therapies to just 1–2 months from the 10–12 months of a standard review.
“Yes, we are on track. We submitted for regulatory approval, actually, and we are expecting that to take place as early as Q2 this year,” Montarce said at the 2026 JPMorgan Healthcare Conference currently underway in San Francisco.