People with Group 3 pulmonary hypertension (PH) associated with interstitial lung disease now have a Food and Drug Administration (FDA)-approved treatment option. Group 3 PH is caused by chronic lung disease or low oxygen levels.
The FDA recently approved Tyvaso (treprostinil) Inhalation Solution to improve exercise ability for people who have PH associated with interstitial lung disease. Manufactured by United Therapeutics, Tyvaso is the first FDA-approved treatment for Group 3 PH.
Catherine Falardeau, who participated in a clinical trial for Tyvaso, says treatment has significantly improved her exercise ability, breathing and quality of life.
During the trial, which ran from February 2018 through September 2020, her six-minute walk tests improved on every visit. Before 2018, Catherine couldn’t walk to her mailbox. Now, she walks her dogs nightly around her neighborhood. She says stairs are still difficult, but she tries to use them at her doctor’s office.
Catherine, who was diagnosed in 2018 with interstitial lung disease-associated PH says Tyvaso also improved her outlook. In December, she changed her diet and since has lost 20 pounds.
“It meant so much to be part of a successful study,” she says. “The only thing that tops it is the feeling of hope. I feel so much better.”
Interstitial lung disease is a group of lung diseases characterized by marked scarring or fibrosis within the lungs. Symptoms include shortness of breath with activity, labored breathing and fatigue.
Adults with interstitial lung disease and PH typically experience worsened shortness of breath, poor exercise tolerance and increased mortality, resulting in a poor quality of life.
An FDA-approved inhaled treatment is exciting for patients and their physicians, Aaron Waxman, M.D., Ph.D., director of Brigham and Women’s Hospital’s pulmonary vascular disease program, said in the United Therapeutics news release.
“This will change the way we manage these patients,” he said in the statement.
PH is thought to affect at least 15% of people with early-stage interstitial lung disease, including 30,000 people in the United States, and about 86% of patients with more severe ILD.
Tyvaso has been approved since 2009 to improve exercise ability among people with pulmonary arterial hypertension (Group 1 PH).
Learn about PH-related clinical trials, and what you need to know to participate in research.