The FDA issued its third approvable letter, stating that Encysive’s development program for Thelin did not demonstrate the evidence of effectiveness needed for approval. The FDA did note, however, that the development program provides some evidence that the drug improves exercise tolerance in PAH.
The FDA is asking Encysive to conduct an additional study to demonstrate the drug’s effectiveness in exercise capacity as measured by change in six-minute walk distance.
As a result of the decision, the company may have to make infrastructure and workforce cuts, and is reviewing strategic alternatives.
“We believe we adequately addressed the issue raised by the FDA in the second approvable letter and we are deeply disappointed in their decision. Encysive remains committed to Thelin in Europe, Australia and Canada, where it has been approved for sale,” commented Bruce Given, president and CEO of Encysive Pharmaceuticals.