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AbbVie sues EMA to block Humira data release

Pharma company seeks injunction following FOI requests for raw data

AbbVie trial data Humira EMA

AbbVie has filed a lawsuit against the European Medicines Agency (EMA) in a bid to stop the regulator from releasing data on its blockbuster arthritis drug Humira.

The pharma company is seeking an injunction to block EMA from releasing detailed data on the effects of Humira (adalimumab) in individual patients in clinical trials for rheumatoid arthritis, according to a Financial Times report.

AbbVie's move - which is backed by US and EU industry groups - comes in the wake of a Freedom of Information requests to the EMA for access to raw data on Humira's safety and efficacy, says the FT, which notes that a separate action against the agency has been filed by InterMune.

One of the companies seeking the information is reported to be UCB, which makes rival arthritis drug Cimzia (certolizumab pegol).

The EMA pledged last year to proactively publish trial data once a drug has completed the marketing-authorisation process, and started a consultation process to examine how it will make data available in practice.

The agency has set a deadline of the start of 2014 for the new transparency initiative to come into effect.

The EMA's announcement has seen battle lines being drawn up over the contentious issue. Shortly after the EMA met in November to set out a timeframe for its proposals, the European Federation of Pharmaceutical Industries and Associations (EFPIA) issued a warning that the interest of drug developers could be significantly harmed if data is released indiscriminately.

EFPIA said at the time it was concerned about patient confidentiality and that competing companies may be able to access sensitive information about each other's medicines.

And last month, the UK's Ethical Medicines Industry Group (EMIG) chimed in with a position paper which said companies should provide objective examples of instances where a company has suffered as a result of transparency.

It was important to prevent an information free-for-all that would allow data to be cherry picked and yield "erroneous conclusions", according to EMIG, which represents small and medium-sized pharma companies.

In the other camp, critics have lambasted the pharma industry's approach to clinical data, including Roche's promise last month to provide greater access to trial data for medical researchers, as merely paying lip service to the concept of transparency.

Among them is Peter Gøtzsche, leader of the Nordic Cochrane Centre, who wrote a letter to the British Medical Journal (BMJ) last November calling for European governments to sue Roche for withholding data on its Tamiflu (oseltamivir) product.

11th March 2013

From: Research, Regulatory



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