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

6 hours ago
  • #Pharmaceutical Competition
  • #Obesity Drugs
  • #FDA Approval
  • Eli Lilly's obesity pill Foundayo (orforglipron) was approved by the FDA, marking its entry into competition with Novo Nordisk's Wegovy pill as an alternative to GLP-1 injections.
  • The approval was facilitated by the FDA's voucher program for speedy reviews, targeting national health priorities, with doses up to 17.2 mg in tablet form.
  • While oral treatments like Foundayo are generally less effective than injectables, they offer wider appeal due to convenience, no needle use, easy distribution, and no cold storage requirements.
  • Foundayo lacks the strict dosing restrictions of the Wegovy pill, which must be taken 30 minutes before food or drinks, potentially making it more user-friendly.
  • Price competition is intense, with Lilly adjusting its cash price to up to $299 per month after Novo launched the Wegovy pill at a similar price, undercutting Lilly's initial plans.
  • In efficacy, the Wegovy pill showed 13.6% weight loss in trials, slightly higher than Foundayo's 11.2%, but Novo emphasizes more safety evidence due to its longer market presence.
  • Safety concerns for Foundayo include common GLP-1 side effects like nausea, vomiting, and diarrhea, with no observed liver risks in studies despite being a small molecule drug.
  • The approval process has been controversial, with reports of political interference and Lilly pressuring the FDA for faster reviews, though Lilly asserts it expects a science-based decision.
  • Novo's head start with the Wegovy pill approval in December may impact the adoption of Lilly's Foundayo, setting up a competitive landscape in the obesity drug market.