The European Commission has approved Encysive's Thelin for pulmonary arterial hypertension, or high blood pressure in the pulmonary artery. The move came after the FDA decided it would need to see additional data on the drug before it could be approved. The FDA issued a second approvable letter for Thelin in late July, which Encysive officials say contained one outstanding issue. That raised analysts' concerns that Thelin would not be approved prior to the arrival of Myogen's ambrisentan. There has been some speculation that the FDA may be concerned with the way patients would respond to a combination of Thelin and warfarin, a standard therapy.
- see the release on Thelin for more information