Brazil Approves Mounjaro for Treating Obstructive Sleep Apnea in Adults With Obesity

Overview

• Anvisa’s resolution was signed on Oct. 17 and published on Oct. 20 in the Diário Oficial da União, formalizing the new indication.
• The approval applies to adults with obesity diagnosed with moderate-to-severe obstructive sleep apnea, and the medicine requires a prescription.
• Phase 3 data showed remission or mild disease in about 50% of patients on tirzepatide plus CPAP and 42% on tirzepatide alone after one year, with average weight loss of 20.4 kg (18%).
• Researchers reported large reductions in hourly breathing interruptions versus placebo, and some participants improved to where CPAP use might no longer be necessary.
• Eli Lilly describes it as the first drug validated for sleep apnea in Brazil, with reports noting common mild gastrointestinal side effects and constrained near-term supply due to high global demand.