U.S. pharmaceutical company Eli Lilly (LLY) says that the weight-loss pill it is developing should be a candidate for fast-track approval under the U.S. Food and Drug Administration’s (FDA) new policies.
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Management at Eli Lilly says the pill called Orforglipron meets most of the criteria to qualify for the FDA’s national priority voucher, an accelerated approval review of new medications. The company plans to submit its review package for the weight-loss pill to the FDA by year’s end and seek an expedited review.
In June of this year, the FDA launched a new program under which its commissioner can award vouchers to national‑priority drugs, shortening review times to one or two months from about 10 to 12. Priority criteria include innovative medicines, addressing unmet health needs, and boosting domestic U.S. manufacturing.
Production Underway
Eli Lilly is gearing up for a big launch of Orforglipron in the second half of 2026. The Indianapolis-based drug maker is already manufacturing the weight-loss pill and storing it at company warehouses, ready to ship as soon as it receives the expected regulatory approval from the FDA.
The weight-loss pill was shown to help patients lose 12% of their body weight in a late-stage clinical trial, and the company has spent billions of dollars on new U.S. plants and facilities to produce the medication. Orforglipron is expected to be a gamechanger for weight-loss drugs, which are currently taken by injection.
Is LLY Stock a Buy?
The stock of Eli Lilly has a consensus Strong Buy rating among 22 Wall Street analysts. That rating is based on 18 Buy and four Hold recommendations issued in the last three months. The average LLY price target of $909.44 implies 5.40% upside from current levels.
