Dermira secures FDA fast track status for lebrikizumab in atopic dermatitis

lebrikizumab获得FDA快速通道资格用以治疗特应性皮炎

2019-12-12 11:22:56 PHARMACEUTICAL

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According to the US biopharma company, lebrikizumab is a monoclonal antibody that can bind with very high affinity with the Interleukin 13 cykotine. Through this mechanism, the antibody is said to specifically inhibit the formation of the IL-13Rα1/IL-4Rα heterodimer complex and subsequent signalling to block the biological effects of IL-13 in a targeted and efficient manner. IL-13 is considered to be a central pathogenic mediator in atopic dermatitis. The fast track designation is given by the regulator to ensure that important new therapies are available to patients as soon as possible. Dermira chairman and CEO Tom Wiggans said: “We are pleased that the FDA granted lebrikizumab its Fast Track designation and recognizes the unmet need for patients living with moderate-to-severe atopic dermatitis and the potential for lebrikizumab to offer a treatment for this serious condition. “This Fast Track designation puts us one step closer to potentially delivering a new therapeutic option more quickly to patients should the results from earlier Phase 2 studies be confirmed in the ongoing Phase 3 studies assessing the safety, efficacy and tolerability of the investigational therapy.” Currently, the IL-13 inhibitor is being assessed in two phase 3 trials called ADvocate 1 and ADvocate 2. The goal of the two late-stage trials is to confirm its safety and efficacy in adolescent and adult patients, aged 12 years and older, and having moderate-to-severe atopic dermatitis. Previously, the investigational drug was evaluated in two phase 2 clinical trials – TREBLE and ARBAN. In the TREBLE study, the IL-13 inhibitor was assessed for its safety and efficacy in combination with topical corticosteroids, while the ARBAN study evaluated it as a monotherapy. Dermira said that in both the mid-stage studies, data suggested clinical improvements in patients treated with the IL-13 inhibitor. In August 2017, Dermira signed a deal with Roche to acquire exclusive, worldwide rights for the development and commercialisation of lebrikizumab for atopic dermatitis and all other indications with the exception of idiopathic pulmonary fibrosis and other interstitial lung diseases. The licensing deal for the IL-13 inhibitor is worth more than $1.3bn.
根据美国生物制药公司的说法, lebrikizumab 是一种单克隆抗体,可以与白细胞介素13 cykotine 结合,具有很高的亲和力。通过这一机制,抗体被认为特别抑制 IL-13R α1/ IL-4R α杂二聚体的形成,并随后以有针对性和有效的方式阻断 IL-13的生物学效应。 IL-13被认为是特应性皮炎的中心致病性介质。 该快速通道的指定是由监管机构,以确保重要的新疗法可供患者尽快。 Dermira 董事长兼首席执行官 Tom Wiggans 表示:“我们很高兴 FDA 授予 Lebrikizumab 快速通道的称号,并认识到对中度至重度特应性皮炎患者未得到满足的需求,以及 Lebrikizumab 为这种严重疾病提供治疗的潜力。 “如果在正在进行的评估研究治疗的安全性、有效性和耐受性的第三阶段研究中确认早期第二阶段研究的结果,这种快速通道的设计将使我们更快地向患者提供一种新的治疗选择。” 目前, IL-13抑制剂正在进行两个3期试验,称为 ADte1和 ADte2。这两个后期试验的目的是确认其安全性和有效性的青少年和成人患者,12岁以上,有中度至严重的特应性皮炎。 此前,该研究药物在两期临床试验中进行了评估—— TREBLE 和 ARBAN 。在 TREBLE 研究中, IL-13抑制剂的安全性和有效性与局部皮质类固醇联合评估,而 ARBAN 研究评价它为单一疗法。 Dermira 说,在这两项中期研究中,数据显示使用 IL-13抑制剂治疗的患者的临床改善。 2017年8月,除特发性肺纤维化及其他间质性肺疾病外, Dermira 与罗氏(Roche)公司签署协议,收购 Lebrikizumab 用于特应性皮炎及所有其他适应症的开发和商业化的全球独家权利。 IL-13抑制剂的许可协议价值逾13亿美元。

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