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Lilly files for FDA approval as weight pill shows promise in maintenance

The news: Eli Lilly reported that its experimental weight loss pill helped patients maintain weight loss after switching from GLP-1 injections, and said it has filed for FDA approval.

  • In a late-stage study, patients maintained their weight loss when taking Lilly’s anti-obesity pill, orforglipron, for one year after taking Novo’s Wegovy or Lilly’s Zepbound injections for 72 weeks.
  • Patients who switched from Wegovy regained around 2 pounds and those who switched from Zepbound regained around 11 pounds by the end of the study.
  • For context, broader research shows GLP-1 users often regain far more after stopping: A July Stamford Research analysis found they typically regain 60% or more of lost weight within months to a year, even with lifestyle changes. That compares to the study patients who regained less than 1% (Wegovy users) and 4.5% (Zepbound users) of their starting weight.
  • Lilly’s pill in an earlier study showed 12.4% weight loss among patients taking the pill for obesity; Novo’s trials for its Wegovy in a pill showed a 16.6% reduction in body weight.

Why it matters: Lilly and Novo are both readying what will be the first GLP-1 weight loss pills on the market. Pills are expected to broaden the GLP-1 market and will account for 25% of the anti-obesity drug market by 2030, per Goldman Sachs.

  • Lilly submitted orforglipron for FDA approval this week. The experimental drug has been granted the FDA’s new Commissioner’s National Priority Voucher (CNPV), a program intended to cut drug review and approval time from 10-12 months to just 1-2 months.
  • Novo applied for FDA approval of Wegovy in a pill in May and expected a decision before the end of the year. Novo was also granted a fast-track CNPV, but used it for approval of a higher-dose version of Wegovy.

Implications for pharma marketers and consumers: As Lilly and Novo continue to expand their anti-obesity pipelines, they’re also navigating commercial and marketing shifts. Lilly CEO David Ricks has called orforglipron the “GLP-1 for all,” with plans to launch two anti-obesity drugs in the next two years and potentially one per year after that—likening the strategy to annual smartphone upgrades. Novo is similarly segmenting its offerings with a higher-dose injection, its forthcoming pill, and its existing Wegovy shot.

While more weight loss drug products mean more choice for consumers, it also means more complexity. Marketers will need to clearly differentiate products, set realistic expectations, and help telehealth partners and healthcare providers guide patient decisions as new options come to market.

This content is part of EMARKETER’s subscription Briefings, where we pair daily updates with data and analysis from forecasts and research reports. Our Briefings prepare you to start your day informed, to provide critical insights in an important meeting, and to understand the context of what’s happening in your industry. Not a subscriber? Click here to get a demo of our full platform and coverage.

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