On March 24, 2006, Encysive received an approvable letter from the FDA regarding the company’s new drug application (NDA) for Thelin (sitaxsentan sodium) 100mg. The FDA is currently evaluating Thelin as a potential new oral treatment for pulmonary arterial hypertension.
The action letter contained concerns and observations that the FDA said must be satisfied prior to achieving approval, including a request for additional clinical trial work.
“Encysive and the FDA have come to the mutual agreement that the company’s approach to responding to the items outlined in the approvable letter with our existing data set is reasonable, making possible the submission of a complete response,” said Dr Bruce Given, president and CEO of Encysive. “We look forward to continuing our productive relationship with the agency.”
Encysive expects to learn whether the FDA accepts the submission for review or not within the next month.