Developments in Oral Obesity Treatments: Key Information

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Developments in Oral Obesity Treatments: Key Information

Injectable medications such as Wegovy are currently utilized by millions of individuals for weight management. However, these weekly injections present limitations concerning patient suitability and cost.

Experimental oral medications, designed to achieve comparable outcomes, are currently under development. The first of these may receive approval from the Food and Drug Administration (FDA) by the end of the year. Organizations like the Obesity Action Coalition, which receives funding from pharmaceutical companies including Novo Nordisk, Eli Lilly, and Pfizer, express support for new treatment innovations for chronic diseases such as obesity.

Key Information on Upcoming Pills

1. Two New Oral Medications Anticipated

  • Novo Nordisk's Oral Semaglutide: This pill contains semaglutide, the same active ingredient found in Wegovy, Ozempic, and the Type 2 diabetes pill Rybelsus. The new oral formulation contains a higher dose of semaglutide. It is expected to be among the first to gain approval.
  • Eli Lilly's Orforglipron: Eli Lilly, the manufacturer of Zepbound and Mounjaro, is developing an obesity pill featuring a novel ingredient called orforglipron, distinct from its injectable tirzepatide.

2. Daily Dosing and Absorption Mechanisms

Unlike weekly injectable treatments, these oral medications require daily administration.

  • Novo Nordisk's Semaglutide Pill: Formulated to prevent immediate breakdown in the stomach, this pill includes sodium N-(8-[2-hydroxybenzoyl]amino)caprylate (SNAC). SNAC creates a temporary protective environment, reducing stomach acidity and increasing cellular permeability, allowing semaglutide absorption within approximately 30 minutes. It must be taken on an empty stomach.
  • Eli Lilly's Orforglipron: This compound exhibits greater stability in the stomach and does not require specific food or water restrictions for effective absorption.

3. Efficacy and Side Effect Profile

Clinical trials have provided data on the effectiveness of these medications:

  • Novo Nordisk's 25 mg Semaglutide Pill: A study published in the New England Journal of Medicine indicated an average weight reduction of 16.6% over 64 weeks, which is comparable to the injectable Wegovy.
  • Eli Lilly's Orforglipron: At its highest dose, orforglipron resulted in an average weight loss of 12.4% over 72 weeks, which is lower than that observed with existing injectable treatments.
  • Side Effects: Both oral drugs share similar side effects with their injectable counterparts, including nausea and diarrhea.

4. Anticipated Cost and Affordability

Oral medications typically have lower manufacturing costs than injectables, suggesting a potentially more affordable price point. Current brand-name injectable obesity medications have list prices exceeding $1,000 per month, raising concerns about patient access and insurance coverage.

A KFF poll indicated that one in eight individuals are currently using this class of injectable drugs, with over half reporting difficulties with affordability despite having some insurance coverage.

Recent agreements involving Novo Nordisk and Eli Lilly with the Trump administration state that if their oral obesity medicines are approved, they will be sold directly to consumers for $149 per month without requiring health insurance. For comparison, current direct-purchase prices for injectables include Zepbound at $299 per month and Wegovy at $349 per month. Increased insurance coverage for the pills could lead to even lower patient copays.

5. Regulatory Timeline and Future Developments

  • FDA Approval: Novo Nordisk's oral obesity pill is anticipated to receive FDA approval before the end of the current year. Eli Lilly plans to submit orforglipron for FDA approval this year, with a priority review voucher potentially expediting the decision process to within months.
  • Next-Generation Drugs: Both companies are advancing new compounds. Novo Nordisk is studying cagrilintide and a combination of cagrilintide and semaglutide. Eli Lilly is investigating retatrutide. Both are in Phase 3 clinical trials.
  • Other Market Entrants: Metsera is also developing several obesity drugs, though none have reached late-stage clinical trials. Pfizer acquired Metsera in a deal potentially exceeding $10 billion.