United Therapeutics' Trevyent NDA For PAH Accepted By FDA
Zacks Investment Research | Sep 11, 2019 11:25PM ET
United Therapeutics Corporation’s (NASDAQ:UTHR) new drug application for its drug-device combination product, Trevyent, was accepted for review by the FDA. The FDA is expected to give its decision on Trevyent NDA on Apr 27, 2020.
Trevyent is a single-use, pre-filled pump that has been developed by SteadyMed to deliver a two-day supply of treprostinil subcutaneously using SteadyMed’s PatchPump technology to treat pulmonary arterial hypertension (PAH). Trevyent was added to United Therapeutics’ portfolio following the August 2018 merger with SteadyMed.
In 2017, SteadyMed received a refuse-to-file letter from the FDA for Trevyent NDA for want of further information. United Therapeutics resubmitted the NDA in June 2019.
United Therapeutics markets treprostinil under the trade name Remodulin as an injectable formulation, Orenitram for oral use, and Tyvaso as an inhaled formulation to treat PAH.
Shares of United Therapeutics have declined 23.9% this year so far against the Zacks Investment Research
Get The News You Want
Trading in financial instruments and/or cryptocurrencies involves high risks including the risk of losing some, or all, of your investment amount, and may not be suitable for all investors. Prices of cryptocurrencies are extremely volatile and may be affected by external factors such as financial, regulatory or political events. Trading on margin increases the financial risks.
Before deciding to trade in financial instrument or cryptocurrencies you should be fully informed of the risks and costs associated with trading the financial markets, carefully consider your investment objectives, level of experience, and risk appetite, and seek professional advice where needed.
Fusion Media would like to remind you that the data contained in this website is not necessarily real-time nor accurate. The data and prices on the website are not necessarily provided by any market or exchange, but may be provided by market makers, and so prices may not be accurate and may differ from the actual price at any given market, meaning prices are indicative and not appropriate for trading purposes. Fusion Media and any provider of the data contained in this website will not accept liability for any loss or damage as a result of your trading, or your reliance on the information contained within this website.
It is prohibited to use, store, reproduce, display, modify, transmit or distribute the data contained in this website without the explicit prior written permission of Fusion Media and/or the data provider. All intellectual property rights are reserved by the providers and/or the exchange providing the data contained in this website.
Fusion Media may be compensated by the advertisers that appear on the website, based on your interaction with the advertisements or advertisers.