United Therapeutics Gets FDA Approval For Tyvaso

FDA has approved United Therapeutics’ Tyvaso (treprostinil) Inhalation Solution for the treatment of pulmonary arterial hypertension (PAH), using the Tyvaso Inhalation System. 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.

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.

Roger Jeffs, president and chief operating officer of United Therapeutics, said: We are well underway with the modifications to the Tyvaso Inhalation System. 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.