FDA由于纳什导致的纤维化酸的完整响应信

根据互通药物公司的新闻稿，FDA为仇恨酸的新药物申请进行了全新的药物申请，用于治疗纤维化，因为互通药物公司的新闻稿

“今天代表着患有先进纤维化的纳什患者的挫折，患者患者患者待治疗患者，以治疗他们的疾病，”Mark Pruzanski，MD，拦截总裁兼首席执行官，在电话会议期间表示。“这是一个非常具有挑战性的计划，达到这一点，我们相信我们已经说服了应支持药物初步批准的数据，以将其达到患者。我们将迅速移动以获得批准并将其提及有需要的患者。“

根据释放，FDA确定了obeticholic acid的好处（OCA）基于替代组织病理学终点仍然不确定，并且没有足够的潜在风险，以支持加速对患者治疗的批准由于纳什引起的纤维化。FDA推荐该公司从随机全球第3研究中提出了关于OCA的疗效和安全数据的额外分析，以评估对肌肉酸治疗（再生）审判的纤维化的影响，以支持加速批准。此外，FDA表示，应继续研究该研究的长期结果阶段。

该释放注意到OCA的NDA基于来自35项临床试验的数据，并以超过1,700名患有由OCA治疗的纳什患者。

“At no point during the review did the FDA communicate that OCA was not approvable on an accelerated basis, and we strongly believe that the totality of data submitted to date both meet the requirements of the Agency’s own guidance and clearly support the positive benefit-risk profile of OCA,” Pruzanski said in the release. “We are disappointed to see the determination the Agency has reached based on an apparently incomplete review, and without having provided medical experts and patients the opportunity to be heard at the anticipated [advisory committee meeting] on the merits of OCA, which is a designated breakthrough therapy. The FDA has progressively increased the complexity of the histologic endpoints, creating a very high bar that only OCA has so far met in a pivotal phase 3 study. On behalf of the hepatology community, we are very concerned that the Agency’s apparently still evolving expectations will make it exceedingly challenging to bring innovative therapies to NASH patients with high unmet medical need. We plan to meet as soon as possible with the FDA to review the [complete letter response] and discuss options for an efficient path forward to approval.”