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Anvisa Approves Mounjaro as First Drug Treatment for Obstructive Sleep Apnea in Adults With Obesity

Regulators cited late-stage studies showing major weight loss with marked reductions in apnea events.

Overview

  • The resolution was signed on October 17 and published on October 20 in Brazil’s Diário Oficial da União, formalizing the new indication.
  • The authorization covers adults with obesity diagnosed with moderate to severe obstructive sleep apnea and requires a medical prescription.
  • Phase 3 data reported average weight loss of about 20% and large drops in hourly breathing interruptions, with some patients reaching remission or mild disease.
  • Researchers and trial reports noted that some participants reduced or no longer needed CPAP after symptom improvement, though CPAP remains a standard therapy.
  • Manufacturer statements and news reports said the medicine was not yet available in Brazil due to high global demand, despite the regulatory approval.