Navigation Links
United Therapeutics Corporation Withdraws European Marketing Authorization Application for Tyvaso for the Treatment of Pulmonary Arterial Hypertension

SILVER SPRING, Md., Feb. 19 /PRNewswire-FirstCall/ -- United Therapeutics Corporation (Nasdaq: UTHR) announced today that it has withdrawn its Marketing Authorization Application (MAA) for Tyvaso (treprostinil sodium) 0.6 mg/ml nebuliser solution for the treatment of pulmonary arterial hypertension (PAH) in the European Union.

United Therapeutics submitted its MAA for Tyvaso to the European Medicines Agency (EMA) in December 2008.  The data included in the MAA is based upon clinical work performed from 2005 to 2007 by United Therapeutics' wholly-owned subsidiary Lung Rx, LLC.  The MAA was withdrawn following communication from the Committee for Medicinal Products for Human Use (CHMP) of the EMA citing a major objection.  The major objection noted that findings of non-compliance with good clinical practices (GCP) at two clinical sites would preclude a recommendation by the EMA for approval of the MAA for Tyvaso.

"Notwithstanding the fact that the EMA's major objection noted findings of non-compliance with good clinical practices, it is important to note that there were no major objections related to the safety or efficacy of Tyvaso," said Roger Jeffs, Ph.D., United Therapeutics' President and Chief Operating Officer.

"Our revenue growth targets are unaffected by the withdrawal," said Martine Rothblatt, Ph.D., United Therapeutics' Chairman and Chief Executive Officer.  "We have long based our growth targets on the estimated 30,000 diagnosed PAH patients in the US, including approximately 12,000 New York Heart Association Class III patients."

Conference Call

We will host a half-hour teleconference on Friday, February 19, 2010, at 9:00 a.m. Eastern Time. The teleconference is accessible by dialing (888) 211-7449, with international callers dialing (913) 312-0961. A rebroadcast of the teleconference will be available for one week by dialing (888) 203-1112, with international callers dialing (719) 457-0820 and using access code 3784360.

This teleconference is also being webcast and can be accessed via our website at

About Tyvaso

Tyvaso is an inhaled medicine used to treat PAH, a life-threatening disease that constricts the flow of blood through the pulmonary vasculature.  Tyvaso contains the same active ingredient (treprostinil) as Remodulin (treprostinil) Injection, which is also approved for the treatment of PAH.  Tyvaso is marketed by United Therapeutics and its wholly-owned subsidiary, Lung Rx, LLC.

About United Therapeutics

United Therapeutics Corporation is a biotechnology company focused on the development and commercialization of unique products to address the unmet medical needs of patients with chronic and life-threatening conditions.

Forward-looking Statements

Statements included in this press release concerning the impact of the GCP shortcomings identified by the EMA, the benefits of Tyvaso for patients, the number of diagnosed US PAH patients, and our revenue growth targets are "forward-looking statements" within the meaning of the safe harbor contained in the Private Securities Litigation Reform Act of 1995.  These forward-looking statements are qualified by the cautionary statements, cautionary language and risk factors set forth in our periodic reports and documents filed with the Securities and Exchange Commission, including our most recent Annual Report on Form 10-K, Quarterly Reports on Form 10-Q and current reports on Form 8-K, which could cause actual results to differ materially from anticipated results.  We are providing this information as of February 19, 2010, and assume no obligation to update or revise the information contained in this press release whether as a result of new information, future events or any other reason.  [uthr-g]

Tyvaso and Remodulin are registered trademarks of United Therapeutics Corporation.

SOURCE United Therapeutics Corporation

Back to top



SOURCE United Therapeutics Corporation
Copyright©2010 PR Newswire.
All rights reserved

Related medicine news :

1. Coalition for Pulmonary Fibrosis Launches Aggressive Ad Campaign Directed at United States Congress
2. United States continues to have highest level of health spending
3. United Medicorp, Inc.s Shareholders Approve All Proposals
4. Proven Terumo Coronary Guidewire Technology Is Now Available in the United States
5. Medical Services International Received Its First Order for Testing By Regulatory Agencies in the United States
6. Peoples United Financial CEO Has Surgery
7. Statement by Mike Leavitt Secretary of Health and Human Services on the United States-China Bilateral Meetings on Food and Drug Safety
8. More Than 100 Organizations Call for a National AIDS Strategy to End the Epidemic in the United States
9. Akers Biosciences, Inc. ABI or the Company Receipt of Further United States Military Contracts
10. Universal Health Care Coverage in the United States
11. Women Deliver Conference to Feature United Nations Leaders
Post Your Comments:
(Date:12/1/2015)... ... ... Growth in medical payments per workers’ compensation claim in Louisiana slowed from 2011 ... according to a recent study by the Workers Compensation Research Institute (WCRI). , ... per claim with more than seven days of lost time continued to be higher ...
(Date:12/1/2015)... Wayland, MA (PRWEB) , ... December 01, 2015 , ... ... adults has a tattoo — a number even greater among Millennials (a whopping one ... there are more and more people who are dissatisfied with their ink. In fact, ...
(Date:12/1/2015)... ... December 01, 2015 , ... ... technicians must mark the film for accurate interpretation by the radiologist. The marking ... an inventor from Sacramento, Calif., has found a way to alleviate this problem. ...
(Date:12/1/2015)... ... 01, 2015 , ... Next IT Healthcare, the leader in ... this year’s Fierce Innovation Awards: Healthcare Edition, an awards program from the publisher ... in the category of Digital Solutions for its innovative, industry-leading product, Alme Health ...
(Date:12/1/2015)... ... December 01, 2015 , ... ... Effective Post-Affiliation Integration ,” addresses a main “pain point” for merging or aligning ... results, once a deal is signed. This quick-read guidance suggests that failing ...
Breaking Medicine News(10 mins):
(Date:12/1/2015)... , Dec. 1, 2015 Relmada Therapeutics, Inc. ... treatment of chronic pain, announced today that the company will ... be held December 1-3 at the Luxe Sunset Boulevard Hotel ... Traversa , CEO of Relmada Therapeutics, will present on Thursday, ... Time). . Please register at least 10 ...
(Date:12/1/2015)... 2015 CytRx Corporation (NASDAQ: CYTR ), ... today announced that it has reached its enrollment target ... 3 clinical trial of aldoxorubicin in patients with previously ... be completed in Q1 2016. The Phase 3 trial is ... Protocol Assessment from the FDA at 79 sites in ...
(Date:12/1/2015)... , Dec. 1, 2015  Today, ... the launch of CareFront, a first-of-its-kind population health ... diagnosed with cancer. Designed to be built into ... cancer patients with resources for their care and ... program also offers tools to help patients understand ...
Breaking Medicine Technology: