EU court upholds EMA's decisions on transparency

The EU General Court upheld in three separate rulings EMA's decision to release documents -- including superiority data for an approved Orphan drug -- requested under EMA's transparency regulations. EMA said the court rejected the suing companies' claims that releasing the disputed documents would "undermine their commercial interests."

One case pertained to CHMP's decision to provide similarity and superiority assessment reports for approved Orphan drug Vantobra inhaled tobramycin from Pari GmbH (Starnberg, Germany) to the Novartis Europharm Ltd. unit of Novartis AG (NYSE:NVS; SIX:NOVN), which had already received EU approval -- and market exclusivity -- for TOBI Podhaler in the same indication. Orphan drugs approved in the EU receive 10 years of market exclusivity, but additional drugs for the indication can receive approval if shown to be similar and clinically superior...