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诺和诺德接受因药物审批信息披露不及时遭受处罚

来源:生物谷 2014-08-20 09:55

2014年8月20日讯 /生物谷BIOON/ --诺和诺德公司本周日宣布公司接受丹麦相关管理部门做出的处罚决定,原因是诺和诺德未能及时披露其治疗糖尿病药物Tresiba(德谷胰岛素)和Ryzodeg(德谷胰岛素/胰岛素)未能获得FDA上市申请。去年12月,丹麦有关部门指责诺和诺德在2013年2月10日才公布FDA有关审批决定,而不是在接到通知当晚(既2013年2月8日)就及时公布这一信息。丹麦有关部门为此开出了50万丹麦克朗(约9万美元)的罚单。

对此,诺和诺德最终决定接受处罚但表示,公司已经尽到了及时通知的义务,之所以未选择接到通知后立刻进行披露,主要是出于详细分析这份通知中的内容,因为该通知要求公司需提交更多药物对心血管方面的影响。不过,出于某种原因,公司最终表示服从处罚以避免长期诉讼的可能。本月早些时候,诺和诺德研究部门表示,Tresiba对心血管影响的研究进展顺利,公司可能将重新向FDA提交申请这一药物。

2012年,诺和诺德的Tresiba和Ryzodeg就已经通过了日本医药管理部门的审批上市,去年一月份,这两种疗法也获批在欧盟市场销售。诺和诺德是目前世界上最大的糖尿病药物研发公司之一,市场上只有赛诺菲、礼来等少数公司能与其分庭抗礼。(生物谷Bioon.com)

详细英文报道:

Novo Nordisk announced Monday that it agreed to pay a fine of 500 000 Danish kroner ($90 000) imposed by authorities in Denmark for failing to inform investors soon enough that the FDA had declined to approve its diabetes drugs Tresiba (insulin degludec) and Ryzodeg (insulin degludec/insulin aspart). In December, Novo Nordisk disclosed that the Danish Financial Supervisory Authority reported the company to police for having waited until February 10, 2013, to tell investors about the FDA's complete response letter, rather than on the evening of February 8 when it first learned of the decision.

The drugmaker reiterated that it had revealed news of the FDA's decision "in a timely manner," saying it was entitled to delay the disclosure in order to adequately assess the impacts of the complete response letter, in which the agency requested more data from a dedicated cardiovascular outcomes trial. "However, for resource reasons, [our] management has chosen to accept the fine to avoid a lengthy lawsuit," the company said, adding "this will finally settle the case."

Earlier this month, Novo Nordisk stated during its second-quarter results presentation that the DEVOTE cardiovascular outcomes trial for Tresiba is "progressing ahead of plans" and it now expects to have data to support an interim analysis around the turn of 2014 to 2015. Further, the company indicated that it expects to re-file the application for Tresiba with the FDA in the middle of next year, with a US launch anticipated for the start of 2016, if approved.

Japanese regulators initially approved Tresiba and Ryzodeg in 2012, and both therapies were cleared in Europe in January of last year.

 

 

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