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United Therapeutics Shares Rise 15% as FDA Clears Pathway to Launch Tyvaso to Treat PH-ILD

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United Therapeutics shares reached a new 52-week high after the firm reported that the U.S. FDA granted approval to commercially launch its Tyvaso® Inhalation Solution to treat patients with pulmonary hypertension associated with interstitial lung disease.

Biotechnology company United Therapeutics Corp. (UTHR:NASDAQ) today announced that "the U.S. Food and Drug Administration (FDA) has approved Tyvaso® (treprostinil) Inhalation Solution for the treatment of patients with pulmonary hypertension associated with interstitial lung disease (PH-ILD; WHO Group 3) to improve exercise ability." The firm advised that this represents the second approved indication for Tyvaso by the FDA which had previously granted approval for the drug in treating pulmonary arterial hypertension (PAH; WHO Group 1) to also improve exercise ability.

Chair of the INCREASE Study Steering Committee and Director of the Pulmonary Vascular Disease Program at Brigham and Women's Hospital Aaron Waxman, M.D., Ph.D., remarked, "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."

"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," Dr, Waxman added.

The company explained that typically in interstitial lung disease (ILD) marked scarring or fibrosis of the bronchioles and alveolar sacs occurs within the lungs. The report mentioned additionally that "increased fibrotic tissue in ILD prevents oxygenation and free gas exchange between the pulmonary capillaries and alveolar sacs and the condition can present with a wide range of symptoms, including shortness of breath with activity, labored breathing, and fatigue." The firm noted that ILD is often accompanied by pulmonary hypertension (PH). United Therapeutics indicated that there are about 30,000 PH-ILD patients in the U.S.

The company's Chair and CEO Martine Rothblatt, Ph.D., commented, "The FDA approval of Tyvaso for patients with PH-ILD is a landmark treatment advancement for this vulnerable patient population...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."

Michael Benkowitz, President and COO of United Therapeutics, added, "With this approval representing such a breakthrough for PH-ILD patients, we're treating this indication launch with a sense of urgency...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."

The firm advised that the FDA approved its supplemental New Drug Application (sNDA) for Tyvaso for PH-ILD based highly upon the results from the Phase 3 INCREASE trial which was a multicenter, randomized study of adult patients with PH-ILD. The clinical study enrolled 326 patients and successfully met its pre-defied primary endpoint of the demonstration of significant improvement in six-minute walk distance (6MWD). In addition, Tyvaso fared well showing substantial improvements in each of the secondary endpoints which were listed as "reduction in the cardiac biomarker NT-proBNP, time to first clinical worsening event, change in peak 6MWD at week 12 and change in trough 6MWD at week 15."

The company stated that TYVASO® (treprostinil) Inhalation Solution is a prostacyclin mimetic that has now received FDA approval indicated for the treatment of pulmonary arterial hypertension to improve exercise ability.

United Therapeutics is a biotechnology company based in Silver Spring, Md. Through its wholly owned subsidiary, Lung Biotechnology PBC, the firm is also focused on addressing the acute national shortage of transplantable lungs and other organs. United is exploring the use of variety of methods and technologies that can possibly delay the need for such transplantable organs or efficiently expand the supply and distribution channels. United pointed out that "Lung Biotechnology is the first public benefit corporation subsidiary of a public biotechnology or pharmaceutical company."

United Therapeutics started the day with a market capitalization of around $7.5 billion with approximately 44.54 million shares outstanding and a short interest of about 5.1%. UTHR shares opened 10.5% higher today at $184.96 (+$17.69, +10.58%) over yesterday's $167.27 closing price and reached a new 52-week high price this morning of $200.00. The stock has traded today between $182.20 and $200.00 per share and closed at $192.34 (+$25.07, +14.99%).


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