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AbbVie Drops EU Court Bid to Block Clinical-Trial Data Release

April 03, 2014

AbbVie Inc. (ABBV:US) dropped its European Union court challenges to block the European Medicines Agency from releasing clinical-trial data from the company.

AbbVie said it decided to withdraw its lawsuits at the EU General Court, the bloc’s second-highest tribunal, after the EMA accepted redacted documents from the company and also its “rationale for removing certain commercially confidential information from the clinical study reports that are at the center of the litigation.”

“A significant portion of data will be disclosed while protecting the information that is commercially sensitive,” AbbVie said in an e-mailed statement.

The EU regulator promised in 2010 to bolster 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’s failed diet pill Acomplia. AbbVie had challenged two decisions by EMA, one from 2012 and one from 2013, that gave access to documents of the marketing authorization of medical products. Biotechnology company InterMune Inc. has a similar appeal against EMA pending.

The EMA fought interim decisions by the EU General Court that blocked the authority from releasing clinical-trial data as long as the challenges by AbbVie and InterMune were pending. The EU’s top court in November said the injunctions blocking EMA had to be re-examined by the lower court.

‘Irreparable’ Harm

AbbVie had told the EU court that companies could suffer “serious and irreparable” harm from the publication of the data.

BEUC, the European Consumer Organization, which was an official participant in the case in favor of EMA, was informed about AbbVie’s request to withdraw the case by the European Court of Justice, Ilaria Passarani, head of the organization’s food and health department said in an e-mail today.

“The fact AbbVie has dropped its lawsuit against the European Medicines Agency disclosing drug trial data is a significant first step,” said Passarani. “It is our strong hope that InterMune, the other complainant, will follow suit.”

The AbbVie cases are: T-29/13, Pending Case, AbbVie v. EMA and T-44/13, Pending Case, AbbVie v. EMA.

To contact the reporter on this story: Stephanie Bodoni in Luxembourg at

To contact the editors responsible for this story: Anthony Aarons at Peter Chapman

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