Eiger BioPharmaceuticals获得FDA对HDV研究的指导

StephenW

Eiger BioPharmaceuticals receive FDA guidance for HDV study
September 24, 2018

Eiger BioPharmaceuticals received written guidance from the FDA for the “D-LIVR” phase 3 study of lonafarnib for patients with hepatitis D, according to a press release.

The guidance confirmed concurrence with the study’s primary endpoint of 2 log10 or more decline in HDV RNA and alanine aminotransferase normalization at 48 weeks.

“This endpoint reflects an improvement in liver condition and virologic response rarely observed in untreated HDV patients, and we have previously demonstrated achievement of this combined endpoint in a substantial number of HDV patients with lonafarnib-based regimens in our phase 2 program,” David Apelian, MD, PhD, MBA, chief operating officer and executive medical officer of Eiger, said in the release.

Patients in the D-LIVR study will receive either all-oral lonafarnib boosted with Norvir (AbbVie, ritonavir) or lonafarnib with ritonavir and pegylated interferon-alfa. The researchers will compare outcomes with an additional placebo arm.

“Eiger is about to begin the first-ever, registration trial with the potential to bring two separate, approved treatment options to HDV patients,” David Cory, president and CEO of Eiger, noted in the release.

The U.S. FDA and European Medicines Agency previously granted orphan drug designation for lonafarnib, and the FDA granted a fast track designation.

Reference: www.eigerbio.com

StephenW

Eiger BioPharmaceuticals获得FDA对HDV研究的指导
2018年9月24日

根据一份新闻稿，Eiger BioPharmaceuticals获得了FDA针对L型肝炎患者进行“D-LIVR”3期研究的书面指导。

该指南证实与该研究的主要终点同时发生，即48周时HDV RNA和丙氨酸氨基转移酶正常化下降2 log10或更多。

“这一终点反映了在未治疗的HDV患者中很少观察到的肝脏状况和病毒学应答的改善，我们之前已经证明在我们的第2阶段计划中，大量基于lonafarnib的方案的HDV患者实现了这种联合终点，”David Apelian ，医学博士，医学博士，MBA，艾格的首席运营官和执行医疗官员在新闻稿中说。

D-LIVR研究中的患者将接受使用Norvir（AbbVie，利托那韦）或使用利托那韦和聚乙二醇化干扰素-α的lonafarnib加强的全口服lonafarnib。研究人员将比较结果与额外的安慰剂组。

“艾格尔即将开始首次注册试验，有可能为HDV患者带来两种独立的，经批准的治疗方案，”Eiger总裁兼首席执行官David Cory在发布中指出。

美国FDA和欧洲药品管理局此前已授予lonafarnib孤儿药名称，并且FDA授予快速通道名称。

参考：www.eigerbio.com