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AbbVie drops legal case against EMA

Accepts publication of new set of redacted Humira data

Pharma company AbbVie has dropped its legal case against the European Medicines Agency (EMA) concerning the release of trial data for one of its medicines.

AbbVie had been attempting to block the regulator from publishing data about its anti-inflammatory drug Humira (adalimumab) – the world's biggest selling prescription drug for 2012 – after requests from other companies and researchers for access to raw data on Humira's safety and efficacy in rheumatoid arthritis.

The EMA confirmed that AbbVie has now shelved this challenge after agreeing to send the regulator a set of documents with updated redactions of certain confidential information as well as justifications for these redactions.

The EMA said: “The very limited redactions proposed by AbbVie were consistent with the Agency's redaction practices and also had no significant impact on the readability of the reports.”

In its own statement, AbbVie justified the use of redactions in the data documents, saying in a statement: "A significant portion of data will be disclosed while protecting the information that is commercially sensitive. As a result, AbbVie has withdrawn its lawsuits."

It follows a long legal process that originally saw the General Court of the EU block the release of the data in April 2013, although a re-examination of this decision was later announced by the European Court of Justice at the end of that year.

Meanwhile, a similar legal battle is still ongoing between the EMA and InterMune, which is challenging the publication of data concerning its only marketed product, the idiopathic pulmonary fibrosis (IPF) drug Esbriet (pirfenidone).

InterMune has been affected by the same Court decisions as AbbVie to data and the EMA has previously said it will not disclose the documents related to the case until the General Court has reached a final conclusion.

Article by
Thomas Meek

4th April 2014

From: Research, Regulatory



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