Product
Tyvaso (treprostinil)

Approval Date
July 30, 2009

Release Date
August 31, 2009

Company
United Therapeutics Corporation

Class
Prostacylin Analog/ Vasodilator and platelet de-aggregator

Indication
Inhalation Solution for the treatment of pulmonary arterial hypertension (PAH). Tyvaso is also 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.

Active Ingredient
Treprostinil

Physician Outlook
United Therapeutics’ Tyvaso (inhaled treprostinil) is a promising new option in the treatment of pulmonary arterial hypertension (PAH). Less frequent dosing as compared to Actelion’s Ventavis, the only other inhaled option for treating PAH, may offer Tyvaso greater patient compliance and convenience. Additionally, Tyvaso will likely be welcomed as an alternative to United Therapeutics’ infused treprostinil, Remodulin.

—Mary McBride, Associate Vice President, Research, GfK Healthcare

Also in the Pipeline (courtesy of Adis R&D Insight)
No competitor compounds in phase III or pre-registration, US.

Pharmacology
Detailed clinical information withheld for review by MPR’s clinical advisory board and will be added as soon as it becomes available.

Clinical Trials
Detailed clinical information withheld for review by MPR’s clinical advisory board and will be added as soon as it becomes available.

Adverse Reactions
Detailed clinical information withheld for review by MPR’s clinical advisory board and will be added as soon as it becomes available.

Adults
Detailed clinical information withheld for review by MPR’s clinical advisory board and will be added as soon as it becomes available.

Children
Detailed clinical information withheld for review by MPR’s clinical advisory board and will be added as soon as it becomes available.

Contraindications
Detailed clinical information withheld for review by MPR’s clinical advisory board and will be added as soon as it becomes available.

Precautions
Detailed clinical information withheld for review by MPR’s clinical advisory board and will be added as soon as it becomes available.

Interactions
Detailed clinical information withheld for review by MPR’s clinical advisory board and will be added as soon as it becomes available.