Suits challenging EMA's transparency policy ongoing

The VP of the European Court of Justice annulled an interim order that prevented EMA from releasing documents in connection to two ongoing suits against EMA challenging the agency's decision to grant access to raw, patient-level data. AbbVie Inc. (NYSE:ABBV) and InterMune Inc. (NASDAQ:ITMN) separately filed suits against EMA earlier this year in response to requests to the agency for data contained in undisclosed MAAs from the companies. In April the European Union General Court ordered EMA to withhold the data. EMA appealed the April order, but despite the annulment the agency said it will not yet release the requested documents. The agency said it does not have timing on when the AbbVie and InterMune suits will be heard by the General Court.

In the interim order, the General Court had said the companies would likely suffer "serious and irreparable damage" if the information was prematurely released. The European Court of Justice said to determine the likelihood of irreparable harm, the lower court needs to assess the clinical and non-clinical information alleged to be confidential (see BioCentury Extra, April 30). ...