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Alexion召回更多罕见病药物Soliris

来源:生物谷 2013-11-13 21:34

2013年11月13日讯 /生物谷BIOON/ --Alexion公司再次宣布召回两批罕见病药物Soliris,原因是药物中存在肉眼可见的颗粒。这也是三个月以来第二次宣布召回该产品。Alexion公司表示所有的三批召回产品都是由相同的生产者在八月份前生产的。Soliris主要是用于治疗一种罕见的致死性血红蛋白尿。但是Alexion公司在生产过程中却频繁出现问题。因此,今年三月份FDA曾因为其产品受到细菌污染而受到警告。(生物谷Bioon.com)

详细英文报道:

Alexion ($ALXN) is again having problems with a contract filler, forcing it to recall two more lots of its rare-disease drug Soliris because of visible particles found in vials. It is the second time in about three months that the company has been in this situation.

The Cheshire, CT, drugmaker said in an SEC filing today that there have been no reports of safety concerns and that the lots in question represent less than 1% of its total inventory, so no supply issues are expected. The company had recalled one lot in August after particulate was found in some retained samples.

The company said all three affected lots came from the same contract vialer and all were filled before August. An investigation led the company to what it believes is the problem, and changes have been made in the process to fix it. The company will take a charge of $10 million to $25 million in the fourth quarter to cover the cost of replacing the affected inventory.

Alexion makes Soliris for the life-threatening blood disorder paroxysmal nocturnal hemoglobinuria, a disease that only affects about 8,000 Americans. The company has struggled this year with production. The FDA issued Alexion a warning letter in March for its Rhode Island manufacturing plant because of issues with bacterial contamination. The following month Alexion brought in a team of experts to help and has told analysts it believes it has already addressed the problems highlighted by the FDA.

 

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