FDA Approves TYVASO (Treprostinil) Inhalation Solution for the Treatment of Pulmonary Arterial Hy...( SILVER SPRING Md. J...),Health

SILVER SPRING, Md., July 30 /PRNewswire-FirstCall/ -- United Therapeutics Corporation (Nasdaq: UTHR) announced today that the United States Food and Drug Administration (FDA) has approved TYVASO (treprostinil) Inhalation Solution for the treatment of pulmonary arterial hypertension (PAH) using the TYVASO Inhalation System (which includes the Optineb-ir device and accessories). TYVASO is indicated to increase walk distance in patients with NYHA Class III symptoms associated with WHO Group I PAH, which includes multiple etiologies such as idiopathic and familial PAH as well as PAH associated with scleroderma and congenital heart disease.

"We are thrilled to have a fourth approval from the FDA for treatment of this serious cardio-pulmonary condition," said Martine Rothblatt, Ph.D., United Therapeutics' Chairman and Chief Executive Officer. "I want to specially recognize Drs. Werner Seeger of Germany and Lew Rubin of the United States for their critical pioneering efforts in making this new therapy possible. TYVASO epitomizes the hopes and dreams we had in forming this company."

In connection with the TYVASO approval, United Therapeutics has agreed to Post-Marketing Commitments (PMC) to modify certain aspects of the TYVASO Inhalation System, perform a usability analysis and collect pharmacokinetic data to verify expected dosing with the modified device. "We are well underway with the modifications to the TYVASO Inhalation System," said Roger Jeffs, Ph.D., United Therapeutics' President and Chief Operating Officer, "And we think these modifications will make the device more patient-friendly. In the meantime, patients will use the current version of the device." We have committed to complete the PMC no later than October 31, 2010.

Additionally, United Therapeutics has agreed t
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