Eli Lilly’s Weight-Loss Pill Seeks Fast-Track FDA Approval
Eli Lilly (LLY) is positioning its experimental weight-loss drug Orforglipron for accelerated FDA review under the agency's new priority voucher program. The pharmaceutical giant claims the pill meets most criteria for fast-track designation, which could slash approval timelines from 10-12 months to just 1-2 months.
The Indianapolis-based company has already begun manufacturing and warehousing Orforglipron ahead of a planned 2026 launch. Clinical trials showed the oral medication helps patients lose 12% of body weight—a competitive efficacy profile in the booming anti-obesity drug market.
FDA's priority review program targets innovative therapies addressing unmet medical needs while boosting domestic production. Lilly plans to submit its complete application package by year-end, betting on regulators' growing appetite for metabolic health solutions.
