Report: United Therapeutics Gains Orphan Status for Lung Disease Drug – Source of the Spring

Downtown Silver Spring-based United Therapeutics has received an FDA designation that helps to expand the company beyond its core business, according to areportfrom the Washington Business Journal.

According to WBJ, the Food and Drug Administration last week had awarded orphan drug status to treprostinil. The active ingredient in several of its products, treprostinil has now been permitted to treat patients with idiopathic pulmonary fibrosis (IPF), a progressive lung disease that scars the lungs and impedes breathing. As stated in the report, the company says it now plans to begin a late-stage clinical trial of Tyvaso, its product for pulmonary arterial hypertension containing an inhaled form of treprostinil, for patients with IPF.

Earning the orphan drug designation validates our drive to address orphan diseases, like IPF, with a significant unmet need, United Therapeutics Chairman and CEO Martine Rothblatt said in astatement. The new trial represents a significant move outside the pulmonary hypertension space, but based on data collected during the recent INCREASE study, were confident that inhaled treprostinil can help address clinical gaps presented by existing therapies in IPF.

The orphan drug status win comes after UTposted a strong third-quarter, which beat Wall Street expectations. The company has also been expanding in the downtown Silver Spring area in recent years, opening theDDOMALand net-zero Unisphere buildings and purchasing the8808 Cameron St.building.

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Report: United Therapeutics Gains Orphan Status for Lung Disease Drug - Source of the Spring