The FDA has handed Encysive its fourth--that's right, fourth--dose of bad news for Thelin, a pulmonary arterial hypertension treatment. Encysive received its first approvable letter for the drug back in March of 2006, when the FDA said that another Phase III trial would be necessary to prove the drug met efficacy standards. Encysive chose not to run the costly trial and has spent the last year and a half trying to change the FDA's mind. After the third approvable letter the company asked for formal dispute resolution, which has now been denied. Thelin has already been approved in Europe.
"We continue to believe that the issue raised by the FDA was sufficiently addressed in the NDA and we are reviewing the FDA's response with external experts to determine the next step forward," said George Cole, President and Chief Executive Officer of Encysive. "Simultaneously, our clinical team, together with outside clinical and statistical experts, is developing an additional Phase III study protocol so we can move ahead quickly with a new trial if it is ultimately required for approval in the U.S."
- see Encysive's release on the decision