United Therapeutics wins 2nd FDA approval for PHTN drug Tyvaso

Reassuring news for pulmonary hypertension (PHTN) patients as Tyvaso, an inhaled treatment for PHTN developed by United Therapeutics, has recently attained its second Food & Drug Administration (FDA) approval.

Earlier in 2009, Tyvaso had secured approved by the FDA to treat PHTN patients. However, the latest approval involves the drug’s use to treat patients with interstitial lung disease to improve exercise ability.

Aaron Waxman, M.D., Ph.D., Director, Pulmonary Vascular Disease Program, Brigham and Women’s Hospital, explained that adults facing both interstitial lung disease and PHTN normally have a poor quality of life as to several health issues like poor exercise tolerance, shortness of breath, and increased mortality.

While, Martine Rothblatt, Ph.D., CEO & Chairman, United Therapeutics, said that the FDA approval of Tyvaso for patients with pulmonary hypertension-interstitial lung diseases (PH-ILD) is a treatment option for vulnerable patient population.

She added that the latest development underscores the firm’s commitment towards accelerating innovation in pulmonary hypertension treatment and expanding its reach to patients who can attain the clinical benefit of Tyvaso. United Therapeutics plans to utilize its expertise and expanded infrastructure for this approved inhaled therapy to further its reach to more patients in the United States.

As per Michael Benkowitz, COO & President, United Therapeutics, the latest approval comes as a promising breakthrough for PH-ILD patients. Their firm is treating this indication launch with a sense of urgency and have already expanded its field-based teams by 40% to educate the ILD community on the benefits of Tyvaso and the diagnoses of PH-ILD.

Mr. Benkowitz further said that their firm anticipates rapid uptake of Tyvaso in this indication and projects a double in the number of patients on Tyvaso therapy by late 2022, conditioned to any COVID-related delays.

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