Get 40% Off
🤯 This Tech Portfolio is up 29% YTD! Join Now to Get April’s Top PicksGet The Picks – Just 99 USD

United Therapeutics' (UTHR) Tyvaso DPI NDA Gets CRL From FDA

Published 10/18/2021, 10:29 PM
Updated 07/09/2023, 06:31 AM

United Therapeutics (NASDAQ:UTHR) UTHR announced that the FDA has issued a complete response letter to its new drug application (“NDA”) for its drug device combination therapy, Tyvaso Dry Powder Inhaler or Tyvaso DPI.

The NDA is seeking approval for the candidate to treat pulmonary arterial hypertension (“PAH”) and pulmonary hypertension associated with interstitial lung disease (“PH-ILD”). Tyvaso DPI comprises the dry powder formulation of United Therapeutics’ PAH medicine, Tyvaso (treprostinil), and a small, portable, dry powder inhaler.

Per the complete response letter (“CRL”) issued to the company, the FDA identified a deficiency preventing approval of Tyvaso DPI, related to an open inspection issue at a manufacturing facility operated by United Therapeutics’ partner MannKind (NASDAQ:MNKD) Corporation MNKD that performs analytical testing of the drug. This prevented the FDA from approving the NDA in its present form.

Shares of both Mannkind and United Therapeutics were down 18.3% and 1.5%, respectively, in intra-day trading on Oct 18, following the above news. Nonetheless, in the year so far, United Therapeutics’ shares have rallied 21.4% against the industry’s 16.9% decline.

Zacks Investment ResearchImage Source: Zacks Investment Research

Following the CRL, the company anticipates that the FDA’s query regarding the deficiency can be resolved quickly and it can obtain approval for Tyvaso DPI in the United States by the summer of 2022.

The drug-device product offers some benefits over nebulized Tyvaso Inhalation Solution, which is already approved in the United States for the treatment of PAH and PH-ILD. Tyvaso DPI is expected to be less time-consuming to administer, and more mobile and convenient. The NDA filing was based on data from the BREEZE study.

If approved, United Therapeutics expects Tyvaso DPI to double the number of patients on Tyvaso by 2022.

United Therapeutics has developed Tyvaso DPI in collaboration with MannKind. The FDA did not report any deficiencies in its CRL with regard to operations at MannKind's device manufacturing and testing facility for Tyvaso DPI.

Please note that United Therapeutics filed the NDA for Tyvaso DPI earlier this year in April with a priority review voucher. The FDA accepted the NDA and granted priority review to the NDA in June 2021.

Please note that United Therapeutics is a market leader in PAH medicines. Other than Tyvaso, which is an inhaled version of treprostinil, the company markets three other PAH medicines in the United States — Remodulin, an injectable formulation of treprostinil approved for both subcutaneous and intravenous use; Orenitram, an oral version of treprostinil; and Adcirca tablets. United Therapeutics bought exclusive rights to commercialize Adcirca (tadalafil) for PAH in the United States from Eli Lilly LLY in November 2008. Eli Lilly markets tadalafil as Cialis for erectile dysfunction. Adcirca/Cialis lost exclusivity in 2018 and generic versions are available.

Zacks Rank & Stock to Consider

United Therapeutics currently carries a Zacks Rank #3 (Hold). A better-ranked stock in the same sector is Xencor (NASDAQ:XNCR) XNCR, which carries a Zacks Rank #1 (Strong Buy) at present. You can see the complete list of today’s Zacks #1 Rank stocks here.

Xencor’s earnings per share estimates for 2021 have narrowed from $0.75 to $0.33 in the past 60 days. The same for 2022 has narrowed from $3.14 to $2.92 over the same period.


Zacks' Top Picks to Cash in on Artificial Intelligence

In 2021, this world-changing technology is projected to generate $327.5 billion in revenue. Now Shark Tank star and billionaire investor Mark Cuban says AI will create "the world's first trillionaires." Zacks' urgent special report reveals 3 AI picks investors need to know about today.

See 3 Artificial Intelligence Stocks With Extreme Upside Potential>>

Want the latest recommendations from Zacks Investment Research? Today, you can download 7 Best Stocks for the Next 30 Days. Click to get this free report

MannKind Corporation (MNKD): Free Stock Analysis Report

Eli Lilly and Company (NYSE:LLY): Free Stock Analysis Report

United Therapeutics Corporation (UTHR): Free Stock Analysis Report

Xencor, Inc. (XNCR): Free Stock Analysis Report

To read this article on Zacks.com click here.

Zacks Investment Research

Latest comments

Risk Disclosure: 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.
© 2007-2024 - Fusion Media Limited. All Rights Reserved.