According to United Therapeutics, the FDA has granted orphan drug designation to treprostinil for the treatment of patients with idiopathic pulmonary fibrosis (IPF), with the designation’s benefits applying to both Tyvaso inhalation solution and Treprostinil Technosphere dry powder treprostinil. United Therapeutics also said that the FDA has cleared the company’s IND for the Phase 3 TETON study of Tyvaso in IPF patients, and enrollment is expected to begin in 2021.
In February 2020, United Therapeutics announced that the Phase 3 INCREASE study of Tyvaso for the treatment of pulmonary hypertension associated with interstitial lung disease (PH-ILD) met its primary endpoint. The company has been partnered with MannKind on the development of the treprostinil DPI since 2018. Earlier this year, United Therapeutics filed a patent infringement suit against Liquidia Technologies, which is developing a dry powder treprostinil for the treatment of pulmonary arterial hypertension (PAH); Liquidia recently received a CRL from the FDA in response to its NDA for that DPI.
United Therapeutics Chairman and CEO Martine Rothblatt commented, “We’re excited that treprostinil has received orphan drug designation, as it validates our drive to address orphan diseases, like IPF, with a significant unmet need. TETON 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.”
Read the United Therapeutics press release.
