EU Medical Agency Appeals Clinical-Trial Data Release Ruling
The European Medicines Agency appealed rulings that blocked it from releasing clinical-trial data from AbbVie Inc. (ABBV) and biotechnology company InterMune Inc. (ITMN) at the European Union’s highest court.
EMA is challenging a lower EU tribunal’s decisions to block the data release while AbbVie’s and InterMune’s main appeals were pending. EMA’s appeal was filed with the EU Court of Justice on July 5, according to the Luxembourg-based court’s website.
The EU regulator promised in 2010 to bolster its transparency by disclosing, on demand, clinical trial data for every drug reviewed. Drug safety activists pressed for the move amid concerns over suicide risks linked to Sanofi (SAN)’s failed diet pill Acomplia.
AbbVie declined to comment on the appeal, Gwenan White, a spokeswoman in the company’s U.K. office, said in a telephone interview. EMA spokeswoman Monika Benstetter declined to immediately comment.
The cases are: C-389/13 P, EMA v. AbbVie, C-390/13 P, EMA v. InterMune U.K. and Others.
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