United Therapeutics Secures Second FDA Approval for Pulmonary Hypertension Drug

Downtown Silver Spring-based United Therapeutics has secured a second Food & Drug Administration approval for its Tyvaso drug, according to a report from Washington Business Journal.

Tyvaso, which was originally approved by the FDA in July of 2009 to treat patients with pulmonary arterial hypertension to improve exercise ability, is now approved for the treatment of patients with pulmonary hypertension associated with interstitial lung disease to improve exercise ability.

“Adults living with both interstitial lung disease and pulmonary hypertension typically have a poor quality of life because of increased shortness of breath, poor exercise tolerance, and increased mortality. Until now, clinicians treating these patients did not have any approved treatment options,” said Aaron Waxman, M.D., Ph.D., Director of the Pulmonary Vascular Disease Program at Brigham and Women’s Hospital and the chair of the INCREASE Study Steering Committee, in a press release. “The regulatory approval of Tyvaso, an inhaled treatment, is exciting news both for patients with PH-ILD and the physicians who treat adults living with this serious, life-threatening disease. This will change the way we manage these patients.”

According to United Therapeutics, Interstitial lung disease (ILD) is a group of lung diseases in which marked scarring occurs within the lungs. It is often complicated by pulmonary hypertension (PH; high blood pressure in the lungs), which further symptoms and decreases survival. PH is estimated to affect at least 15% of patients with early-stage ILD (approximately 30,000 PH-ILD patients in the United States) and may affect up to 86% of patients with more severe ILD.

“The FDA approval of Tyvaso for patients with PH-ILD is a landmark treatment advancement for this vulnerable patient population,” said Martine Rothblatt, Ph.D., Chairperson and Chief Executive Officer of United Therapeutics. “It also underscores our commitment to driving innovation in the field of pulmonary hypertension and expanding the number of patients who can achieve a clinical benefit from Tyvaso. We plan to tap into our experience and expanded infrastructure to bring this safe and effective inhaled therapy to the many patients living with PH-ILD in the United States.”

“With this approval representing such a breakthrough for PH-ILD patients, we’re treating this indication launch with a sense of urgency,” said Michael Benkowitz, President and Chief Operating Officer of United Therapeutics. “We’ve already expanded our field-based teams by 40% to educate the ILD community on the benefits of Tyvaso and how to properly diagnose PH-ILD. We expect rapid uptake of Tyvaso in this indication and expect to double the number of patients on Tyvaso therapy by the end of 2022, barring any COVID-related delays.”

United Therapeutics announced in February that it launched commercial sales of the innovative Remunity Pump for Remodulin, for patients with pulmonary arterial hypertension (PAH). Originally targeted for a July 2020 release, it was delayed for several months due to the pandemic. The announcement came after UT gained orphan status for a drug to treat patients with idiopathic pulmonary fibrosis (IPF), a progressive lung disease that scars the lungs and impedes breathing, last December.

Photo: “File:United Therapeutics.JPG” by Farragutful is licensed under CC BY-SA 3.0