Eli Lilly’s obesity pill approved by FDA, setting up competition with Novo Nordisk

Key Points:

• Eli Lilly’s obesity pill, orforglipron (marketed as Foundayo), was approved by the FDA under a voucher program aimed at speeding reviews for drugs aligned with national health priorities, setting up competition with Novo Nordisk’s Wegovy pill.
• Foundayo is an oral tablet with doses up to 17.2 mg, equivalent to the capsule doses tested in trials, and offers advantages over Wegovy’s pill, such as no restrictions on food or drink intake before taking it.
• Pricing competition is intense, with Lilly initially pricing Foundayo between $149 and $399 per month but lowering it to up to $299 for continuous prescriptions to match Novo’s Wegovy pill price.
• In clinical trials, Wegovy demonstrated slightly higher efficacy with 13.6% weight loss over 64 weeks compared to Foundayo’s 11.2% over 72 weeks; Wegovy also has more established safety data due to its injectable counterpart.
• The FDA’s voucher program used for Foundayo’s approval has faced criticism for potential political interference, with reports that Lilly sought to expedite the agency’s review process, though the company maintains the FDA conducted a science-based evaluation.