参天制药干眼病药物Ikervis（环孢素）获欧盟委员会批准 - 药群论坛

参天制药干眼病药物Ikervis（环孢素）获欧盟委员会批准

发布日期：2015-03-27 来源：生物谷

Ikervis是欧洲上市的首个干眼病处方药，药物活性成分为环孢素（ciclosporin）

日本眼科领域领导者参天制药（Santen Pharma）近日宣布，该公司研发的眼科药物Ikervis（ciclosporin，环孢素）获欧盟委员会（EC）批准，用于经人工泪液治疗未得到改善的干眼病成人患者严重角膜炎的治疗。

干眼症（dry eye）又名角结膜干燥症（KCS），是指任何原因造成的泪液质或量异常或动力学异常，导致泪膜稳定性下降，并伴有眼部不适和(或)眼表组织病变特征的多种疾病的总称。它是目前最为常见的眼表疾病，主要治疗方法是使用人工泪液。

目前，干眼病患者严重角膜炎治疗方面，仍存在着真真实实的治疗挑战。而Ikervis的上市，将为欧洲干眼病患者提供首个处方药，同时标志着该地区严重干眼病患者临床治疗的重大进步。

Ikervis的获批，是基于在欧洲开展的一项III期临床项目的数据。该研究在伴有严重角膜炎的干眼病成人患者中开展，调查了ciclosporin的疗效和安全性。根据所提交的质量、安全性和疗效数据，欧洲药品管理局（EMA）人用医药产品委员会（CHMP）在2015年1月建议批准Ikervis。CHMP审查后认为，Ikervis具有很好的效益-风险平衡，建议批准上市，造福欧洲的干眼病患者。

Ikervis的活性药物成分是环孢素（ciclosporin），这是一种免疫抑制剂，归属于眼科类治疗产品。环孢素能够阻断前炎性细胞因子(pro-inflammatory cytokine)的释放，在眼表细胞发挥抗炎作用。Ikervis的治疗益处是能够改善眼表损伤并减少炎症反应。

参天制药（Santen）是日本眼科治疗领域的领导者，其眼科处方药市场份额居该国首位。（生物谷Bioon.com）

英文原文：Santen announces Approval of Ikervis for EU Marketing Authorization

SantenPharmaceutical Co., Ltd. (Osaka, JAPAN, Tokyo Stock Exchange Code 4536)(Santen) today announced it received approval of the Marketing AuthorizationApplication (MAA) for Ikervis from the European Commission. Ikervis is approvedfor treatment of severe keratitis in adult patients with dry eye disease, whichhas not improved despite treatment with tear substitutes.

The MAA approval was supported by a phase III clinical program investigatingthe efficacy and safety of ciclosporin in European dry eye disease patientswith severe keratitis. based on quality, safety and efficacy data submitted,Ikervis had received a positive opinion from the Committee for MedicinalProducts for Human Use (CHMP) of European Medicines Agency in January, 2015.The CHMP considered that there was a favorable benefit-to-risk balance forIkervis and therefore recommended the granting of the marketing authorization.Ikervis is the first drug for the treatment of severe keratitis in adultpatients with dry eye disease in Europe.

Professor Andrea Leonardi, University of Padua, Italy, added: "Treatmentof severe keratitis in dry eye patients so far represented a real therapeuticchallenge and the availability of Ikervis in Europe will represent asignificant progress in the management of severe dry eye patients."

Masamichi Sato, Head of Santen Europe and President of Santen Holdings EU BV,concluded: "We are delighted with today's MAA approval that offers dry eyedisease patients with severe keratitis the first prescription treatment inEurope. Our commitment is to continue to deliver new treatments for peoplesuffering from dry eye. Ikervis is a tangible result of Santen'spatient-centered approach to innovation."
about Ikervis

The activesubstance of Ikervis® is ciclosporin, an immunosuppressive agent, belonging tothe therapeutic class of ophthalmic products. Ciclosporin blocks the release ofpro-inflammatory cytokines and exerts an anti-inflammatory effect in ocularsurface cells. The benefits with Ikervis are its ability to improve ocularsurface damage and reduce inflammation in dry eye disease patients with severekeratitis.