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ARTICLE | Company News

AbbVie drops suits against EMA

April 5, 2014 12:17 AM UTC

AbbVie Inc. (NYSE:ABBV) dropped two lawsuits against EMA challenging the agency's decision to grant access to raw patient-level data for the company's autoimmune drug Humira adalimumab. AbbVie filed suit last year in response to a third-party request to EMA for data contained in an MAA for Humira for Crohn's disease. AbbVie withdrew its suits after it and EMA reached an agreement on redactions for the requested data.

A related suit filed by InterMune Inc. (NASDAQ:ITMN) against EMA is still ongoing. The case is related to a third-party request for data for the company's idiopathic pulmonary fibrosis (IPF) drug, Esbriet pirfenidone. InterMune said that since Esbriet is its sole marketed product, disclosure of certain data to competitors "would be likely to prejudice the company's interests very substantially." ...