Abbot spinoff AbbVie files to block EU regulator from releasing clinical trials data
11 Mar 2013
US drug maker AbbVie Inc, recently spun-off from Abbott Labarotory, has sued the European drug regulator to prevent it from releasing confidential and commercially-sensitive data of its blockbuster rheumatoid arthritis drug.
AbbVie Inc, which was spun off from Abbott Laboratories earlier in the year, is seeking to stop the European Medicines Agency from releasing data on the effects in individual patients in clinical trials for Humira, the Financial Times yesterday reported.
The European Medicines Agency was to release ''raw data'' on the drug's safety and efficacy after it received two Freedom of Information requests in 2012, said the report.
The report said that the Chicago-based drug maker had confirmed to it that it had filed a suit to block the agency from releasing confidential and commercially-sensitive information on the drug.
AbbVie said that although it has no problem with releasing clinical research and safety information for the benefit of patients and healthcare professionals, it would not allow the disclosure of commercially confidential information.
The outcome of this suit will have wider implications for the London-based agency's 2010 decision to release information to the public from 2014 on drugs that have been approved or rejected by the EU.
