United Therapeutics Corp. is a step closer to getting a new pulmonary arterial hypertension treatment to patients.
The Silver Spring biotech’s New Drug Application for Trevyent, a treatment that uses treprostinil — the same active ingredient in three of United Therapeutics’ existing products — has been accepted by the Food and Drug Administration, the company announced Wednesday.
The FDA will now review the product, a combination of that drug and the technology to inject it subcutaneously, or under the skin. The agency has assigned April 27, 2020, as the target action date under the Prescription Drug User Fee Act — the date by which regulators will complete their review of the drug, United Therapeutics (NASDAQ: UTHR) said in a press release.
It’s a noteworthy milestone for Untied Therapeutics, which bought SteadyMed Therapeutics Inc. last year in a potential $216 million deal that involved Trevyent, SteadyMed’s flagship product. United Therapeutics had offered $2.63 per…Read the full story from the Washington Business Journal.