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歐洲首個干眼病處方藥Ikervis(環孢素)上市

2015年3月27日訊 /生物谷BIOON/ --日本眼科領域領導者參天制藥(Santen Pharma)近日宣布,該公司研發的眼科藥物Ikervis(ciclosporin,環孢素)獲歐盟委員會(EC)批準,用于經人工淚液治療未得到改善的干眼病成人患者嚴重角膜炎的治療。

干眼癥(dry eye)又名角結膜干燥癥(KCS),是指任何原因造成的淚液質或量異?;騽恿W異常,導致淚膜穩定性下降,并伴有眼部不適和(或)眼表組織病變特征的多種疾病的總稱。它是目前最為常見的眼表疾病,主要治療方法是使用人工淚液。

目前,干眼病患者嚴重角膜炎治療方面,仍存在著真真實實的治療挑戰。而Ikervis的上市,將為歐洲干眼病患者提供首個處方藥,同時標志著該地區嚴重干眼病患者臨床治療的重大進步。

Ikervis的獲批,是基于在歐洲開展的一項III期臨床項目的數據。該研究在伴有嚴重角膜炎的干眼病成人患者中開展,調查了ciclosporin的療效和安全性。根據所提交的質量、安全性和療效數據,歐洲藥品管理局(EMA)人用醫藥產品委員會(CHMP)在2015年1月建議批準Ikervis。CHMP審查后認為,Ikervis具有很好的效益-風險平衡,建議批準上市,造福歐洲的干眼病患者。

Ikervis的活性藥物成分是環孢素(ciclosporin),這是一種免疫抑制劑,歸屬于眼科類治療產品。環孢素能夠阻斷前炎性細胞因子 (pro-inflammatory cytokine)的釋放,在眼表細胞發揮抗炎作用。Ikervis的治療益處是能夠改善眼表損傷并減少炎癥反應。

參天制藥(Santen)是日本眼科治療領域的領導者,其眼科處方藥市場份額居該國首位。(生物谷Bioon.com)

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

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

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

Professor Andrea Leonardi, University of Padua, Italy, added: "Treatment of severe keratitis in dry eye patients so far represented a real therapeutic challenge and the availability of Ikervis in Europe will represent a significant 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 eye disease patients with severe keratitis the first prescription treatment in Europe. Our commitment is to continue to deliver new treatments for people suffering from dry eye. Ikervis is a tangible result of Santen's patient-centered approach to innovation."
About Ikervis

The active substance of Ikervis® is ciclosporin, an immunosuppressive agent, belonging to the therapeutic class of ophthalmic products. Ciclosporin blocks the release of pro-inflammatory cytokines and exerts an anti-inflammatory effect in ocular surface cells. The benefits with Ikervis are its ability to improve ocular surface damage and reduce inflammation in dry eye disease patients with severe keratitis.

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