United Therapeutics' Trevyent NDA for PAH Accepted by FDA


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United Therapeutics Corporation ‘s 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 industry ‘s increase of 5.4%.

United Therapeutics has developed another pre-filled, semi-disposable pump system, RemUnity for subcutaneous delivery of Remodulin in partnership with DEKA. In February 2018, DEKA filed RemUnity with the FDA (510(k) filing) that was cleared by the FDA in May 2019. United Therapeutics intends to launch the product after it gets an FDA clearance for a special 510(k) filing, which DEKA plans to submit to the FDA shortly.

RemUnity and Trevyent, if approved, will provide two expanded options for patients on subcutaneous Remodulin.

United Therapeutics has also developed Remodulin Injection in the Implantable System for Remodulin (ISR) in collaboration with Medtronic MDT . It gained FDA approval for this implantable pump for delivering Remodulin intravenously in July 2018.

United Therapeutics and Medtronic pursued parallel regulatory filings related to the device and the drug. The system has been developed to eliminate two biggest problems with Remodulin, subcutaneous pain and life-threatening sepsis risk. The company expects to launch ISR in 2020. RemoPro, a pain-free subcutaneous Remodulin prodrug, is in phase I studies.

In 2018/early 2019, United Therapeutics signed four major agreements to acquire new product candidates including Trevyent.

In January 2019, United Therapeutics acquired worldwide rights to manufacture and develop/commercialize Arena Pharmaceuticals’ ARNA oral, potent, once-daily IP receptor agonist ralinepag. Ralinepag is being developed in late-stage studies for PAH.

In October 2018, United Therapeutics in-licensed MannKind’s MNKD phase III-ready investigational drug-device combination product, Treprostinil Technosphere. The product combines MannKind’s dry inhalation technology with treprostinil for the treatment of PAH. In September, it in-licensed the U.S. and Canadian rights to Samumed’s SM04646, a phase I development-stage oral Wnt pathway inhibitor, to treat idiopathic pulmonary fibrosis.

United Therapeutics currently carries a Zacks Rank #3 (Hold). You can see the complete list of today’s Zacks #1 Rank (Strong Buy) stocks here .

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