Downtown Silver Spring-based United Therapeutics has received an FDA designation that helps to expand the company beyond its core business, according to a report from 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 a statement. The new trial “represents a significant move outside the pulmonary hypertension space, but based on data collected during the recent INCREASE study, we’re confident that inhaled treprostinil can help address clinical gaps presented by existing therapies in IPF.”
The orphan drug status win comes after UT posted 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 the DDOMAL and net-zero Unisphere buildings and purchasing the 8808 Cameron St. building.
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