Biofrontera Says EC Approves Ameluz Label Extension
Biofrontera Says EC Approves Ameluz Label Extension
DJ Biofrontera Says EC Approves Ameluz Label Extension
DJ Biofrontera稱歐盟批准延長Ameluz標籤
By Michael Dabaie
邁克爾·達拜(Michael Dabaie)著
Biofrontera AG said the European Commission has approved the use of its Ameluz in combination with photodynamic therapy for the treatment of actinic keratosis on the extremities and trunk/neck.
Biofrontera AG説，歐盟委員會已經批准將其Ameluz與光動力療法結合使用，用於治療肢體和軀幹/頸部的光化性角化病。
The results of the follow-up phase of the clinical study comparing daylight PDT with Ameluz and Metvix were included in the product information. With a recurrence rate of 19.5%, Ameluz showed lower recurrence rates after 12 months than Metvix with 31.2%, Biofrontera said.
臨牀研究的後續階段比較日光PDT與Ameluz和Metvix的結果包括在產品信息中。Biofrontera説，Ameluz的複發率為19.5%，12個月後的複發率低於Metvix(31.2%)。
The approval of the label extension by the European Commission followed a positive opinion issued by the European Medicines Agency and was based on the results of one Phase III clinical trial with a total of 50 patients.
歐盟委員會批准延長標籤之前，歐洲藥品管理局(European Medicines Agency)發表了積極的意見，並基於對總共50名患者進行的一項第三階段臨牀試驗的結果。
Write to Michael Dabaie at michael.dabaie@wsj.com
寫信給Michael Dabaie，電子郵件：michael.dabaie@wsj.com
(END) Dow Jones Newswires
(完)道瓊通訊社
March 10, 2020 11:31 ET (15:31 GMT)
2020年3月10日美國東部時間11：31(格林尼治標準時間15：31)
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