FDA says it needs additional evidence of effectiveness for Corcept relacorilant

Corcept Therapeutics (CORT) announced that the FDA has issued a complete response letter, or CRL, regarding the new drug application, or NDA, for relacorilant as a treatment for patients with hypertension secondary to hypercortisolism. While the FDA acknowledged that Corcept’s pivotal GRACE trial met its primary endpoint and that data from the company’s GRADIENT trial provided confirmatory evidence, the FDA concluded it could not arrive at a favorable benefit-risk assessment for relacorilant without Corcept providing additional evidence of effectiveness. “We are surprised and disappointed by this outcome,” said Joseph Belanoff, Corcept’s CEO. “Our commitment to patients suffering from the effects of hypercortisolism is unwavering. I am confident we will find a way to get relacorilant to the patients it could help. We will meet with the FDA as soon as possible to discuss the best path forward.”