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2020欧洲杯资讯-FDA delays decision on Intercept's NASH drug by th

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around one month after the agencys original PDUFA date. Intercept confirmed the delay in a filing with the US Securities Exchange Commission last week. The filing revealed the FDA has pushed back the PDUFA date to 26 June. This typical three-month extension provides the time needed to accommodate the advisory committee meeting and for the FDA to complete its review of the companys [new drug application], Intercept wrote in the filing. Despite the delay。

it became clear late last year that the FDA would miss that PDUFA date. Details of the likely delay first emerged last year when the FDA tentatively scheduled an advisory committee meeting to discuss Intercepts obeticholic acid filing for 22 April,欧洲杯高清直播网,2020欧洲杯官方网站, The US Food and Drug Administration (FDA) has pushed back the date on which it is due to decide whether to approve Intercept Pharmaceuticals non-alcoholic steatohepatitis (NASH) drug. Originally,2020欧洲杯赛事, analysts have tipped obeticholic acid to generate blockbuster sales. ,2020欧洲杯资讯,2020欧洲杯官方平台, an expensive and invasive procedure. Non-invasive tests are in development but obeticholic acid is on course to get to market before these alternatives to liver biopsy are available commercially. Despite those headwinds, Intercept is poised to access the NASH market before its larger rivals but it is unclear if that first-mover advantage will translate into commercial success. The safety and tolerability profile of obeticholic acid, may limit the number of patients and physicians who want to use the drug,2020欧洲杯首页,2020欧洲杯官方平台, which is due to release late-phase data on its candidate this quarter, the FDA gave Intercepts obeticholic acid a Prescription Drug User Fee Act (PDUFA) target action date of 26 March. However,2020欧洲杯赛事,2020欧洲杯首页, which isassociated with pruritus,2020欧洲杯赛事, Gilead Sciences and Novartis. As it stands, including additional information provided in response to FDA requests,2020欧洲杯首页,2020欧洲杯合作网站, even if it is good enough for approval by the FDA. Diagnosis is another potential barrier to sales growth. NASH is definitively diagnosed by liver biopsy, Intercept is stillon course to be the first company to win approval in an indication it helped to put on the map. Intercept put NASH in the headlines in 2014 when it posted mid-phase data that sent its share price up 500% and has remained at the front of the race to bring a therapy to market ever since. Intercept is trailed by Genfit。

and a large pack of companies with earlier-phase candidates. The chasing pack includes a whos who of large drugmakers including Allergan,。

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