Peginterferon Lambda获得了D型肝炎的突破性Tx状态

StephenW

August 20, 2019
Peginterferon Lambda Gets Breakthrough Tx Status for Hepatitis D
Brian Park, PharmD
The Food and Drug Administration (FDA) has granted Breakthrough Therapy designation to peginterferon lambda (Lambda; Eiger BioPharmaceuticals) for the treatment of hepatitis delta virus (HDV) infection.

Hepatitis D, an uncommon but severe form of viral hepatitis, only occurs in individuals infected with the hepatitis B virus (HBV). Infection with HDV can lead to more severe liver disease than HBV alone and is associated with rapid hepatic fibrosis, carcinoma, and decompensation.

Lambda is a late-stage, first-in-class, type 3 interferon (IFN) that stimulates cell-mediated immune responses. It targets type 3 IFN receptors that are highly expressed on hepatocytes with limited expression on hematopoietic and CNS cells. Currently, there is no approved therapy for HDV.

The FDA designation is supported by data from the phase 2 LIMT (Lambda Interferon MonoTherapy in Hepatitis Delta Virus) study which evaluated Lambda monotherapy in 33 patients with chronic HDV for 48 weeks with a 24 week follow-up. Results showed that 36% of Lambda-treated patients acheived HDV-RNA below the limit of quantification, comparable to historical peginterferon alfa at week 48; a durable virologic response was achieved in 36% of patients 24 weeks post-treatment.


Regarding safety, the most common treatment-emergent adverse events included mild to moderate flu-like symptoms and elevated transaminase levels.

“We look forward to continued collaboration with the FDA, now on four Breakthrough Therapy Designation programs including both Lonafarnib and Lambda for hepatitis delta virus (HDV) infection, Lonafarnib for Hutchinson-Gilford Progeria Syndrome (Progeria) and Progeroid Laminopathies, and Avexitide for post-bariatric hypoglycemia (PBH),” said David Cory, President and CEO of Eiger.

Lambda was previously granted Orphan Drug and Fast Track designation by the FDA.

For more information visit eigerbio.com.

StephenW

2019年8月20日
Peginterferon Lambda获得了D型肝炎的突破性Tx状态
布莱恩·帕克，医药
美国食品和药物管理局（FDA）已授予peginterferon lambda（Lambda; Eiger BioPharmaceuticals）用于治疗丁型肝炎病毒（HDV）感染的突破性治疗。

D型肝炎是一种罕见但严重的病毒性肝炎，仅发生在感染乙型肝炎病毒（HBV）的个体中。与单独的HBV相比，HDV感染可导致更严重的肝脏疾病，并且与快速肝纤维化，癌和失代偿相关。

Lambda是一种晚期，一流的3型干扰素（IFN），可刺激细胞介导的免疫反应。它靶向在肝细胞上高表达的3型IFN受体，其在造血细胞和CNS细胞上表达有限。没有批准的HDV治疗方法。

美国食品和药物管理局的指定得到了第2阶段LIMT（Lambda干扰素单一疗法在肝炎病毒）研究中的支持，该研究评估了33例慢性HDV患者的Lambda单药治疗48周，随访24周。结果显示，36％的Lambda治疗患者实现了低于定量限的HDV-RNA，与48周时的历史聚乙二醇干扰素α相当;治疗后24周，36％的患者获得了持久的病毒学应答。


关于安全性，最常见的治疗引起的不良事件包括轻度至中度流感样症状和转氨酶水平升高。

“我们期待继续与FDA合作，目前正在进行四项突破性治疗指定计划，包括Lonafarnib和Lambda治疗肝炎病毒（HDV）感染，Lonafarnib治疗Hutchinson-Gilford早衰综合征（Progeria）和Progeroid Laminopathies，以及Avexitide治疗-bariatric lowoglycemia（PBH），“Eiger总裁兼首席执行官David Cory说。

Lambda之前被FDA批准为Orphan Drug and Fast Track。

有关更多信息，请访问eigerbio.com。