Brazil's ANVISA Approves Tyvaso for Rare Pulmonary Hypertension

Brazil's health regulator Agência Nacional de Vigilância Sanitária (ANVISA) has granted registration for Tyvaso (treprostinila), marking the first medication approved in the country to treat pulmonary hypertension associated with interstitial lung disease (HP‑DPI). The drug is delivered by oral inhalation in four daily sessions and is indicated for patients in WHO Group 3, aiming to lower pulmonary arterial pressure, improve blood flow, and enhance exercise capacity and quality of life.

Although the approval was published on 29 April, Tyvaso cannot yet be sold. Its maximum price must first be set by the Câmara de Regulação do Mercado de Medicamentos (CMED), after which the product’s holder will decide when to launch it. Pulmonary hypertension is a rare disease, affecting roughly 2–5 adults per million each year, with an average survival of about 2.8 years.