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news.The FDA has told Encysive Pharmaceuticals that it will need more proof that its pulmonary arterial hypertension drug Thelin is effective before granting approval and has suggested the company conducts an additional study.
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In a response to Encysive’s request for a formal dispute resolution on its new drug application for Thelin, the FDA’s reviewer agreed with the decision of the Division of Cardiovascular and Renal Products that, while the data provided in the NDA are suggestive of the effectiveness of Thelin, it did not provide the substantial evidence of effectiveness needed for approval.
The reviewer encouraged the company to conduct an additional study to demonstrate the drug’s effectiveness in exercise capacity as measured by change in six-minute walk distance.
“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 CEO 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 US.”