Shares of United Therapeutics (UTHR) - Get Report spiked Thursday after the U.S. Food and Drug Administration approved its inhaled treatment drug Tyvaso for patients with pulmonary hypertension associated with interstitial lung disease.
Shares of the Silver Spring, Md., company at last check jumped 18% to $197.22.
This is the second FDA-cleared indication for Tyvaso. The agency in July 2009 approved it to treat pulmonary arterial hypertension, the company said.
"The FDA approval of Tyvaso for patients with PH-ILD is a landmark treatment advancement for this vulnerable patient population," Martine Rothblatt, chairman and chief executive, said in a statement.
Interstitial lung disease is a group of lung diseases marked by scarring within the lungs.
"We're treating this indication launch with a sense of urgency," said Michael Benkowitz, president and chief operating officer, said.
"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," Benkowitz added.
Prior to the FDA clearance, United Therapeutics conducted a study of 326 patients with PH-ILD. The study met its primary endpoint: significant improvement in six-minute walk distance, United Therapeutics said.
"Adults living with both interstitial lung disease and pulmonary hypertension typically have a poor quality of life, said Aaron Waxman, a physician who directs the pulmonary vascular disease program at Brigham and Women's Hospital and is chairman of the steering committee for the study.
They suffer shortness of breath and can't easily tolerate exercise, and they die more frequently, he said.
"Until now, clinicians treating these patients did not have any approved treatment options."