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近日,阿斯利康内分泌产业管线在欧洲监管方面收获重大喜讯,其糖尿病组合疗法Qtern获得欧盟委员会批准,而该药物去年被FDA拒之门外。这次欧盟委员会的批文对阿斯利康意义重大,由于去年十月份FDA表示需要阿斯利康提交更多的临床数据证明该固定剂量组合疗法的有效性,若欧盟监管方面再出现延迟,阿斯利康将很有可能失去业内同类型药物第二名上市的地
Recently, the AstraZeneca endocrine industry pipeline reaped great news in the European regulatory field. Its diabetes combination therapy Qtern was approved by the European Commission, which was rejected by the FDA last year. The approval of the European Commission is of great significance to AstraZeneca. As the FDA said in October last year that it needs AstraZeneca to submit more clinical data to prove the effectiveness of the fixed-dose combination therapy, if there is any further regulatory delay in the EU, AstraZeneca Will likely lose the second place in the industry for the same type of drug listing