美国食品和药物管理局拒绝使用Corcept® 作为高血压的复合剂,原因是皮质醇过多,需要更多证据. FDA rejects Corcept’s relacorilant for hypertension due to excess cortisol, citing need for more evidence.

美国FDA发布了完整的回应信,拒绝Corcept Therapeutics的申请,该公司申请使用因高皮质醇症导致高血压的药物Relcorilant,尽管GRACE和GRADIENT试验的结果是正面的. The U.S. FDA issued a Complete Response Letter rejecting Corcept Therapeutics' application for relacorilant, a drug for hypertension due to hypercortisolism, despite positive results from the GRACE and GRADIENT trials. 该机构指出,为了建立有利的效益风险概况,需要额外证据表明有效性。 The agency stated additional evidence of effectiveness is needed to establish a favorable benefit-risk profile. 这一决定导致Corcick股市下跌约50%, 标志着公司及其投资者遭遇重大挫折。 The decision caused Corcept’s stock to plummet by approximately 50%, marking a significant setback for the company and its investors.