UPDATE 1-CTI pulls EU application for lung drug Opaxio

Wed Sep 23, 2009 5:52pm BST
 
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* Withdrawal due to EU concerns over trial design

* Clearance was expected by company early 2011 (Adds details)

LONDON, Sept 23 (Reuters) - Cell Therapeutics (CTIC.O) (CTIC.MI) has withdrawn its European marketing application for its lung drug Opaxio, after an EU panel raised concerns over the trial design, Europe's drug regulator said on Wednesday.

The European Medicines Agency (EMEA) said it has received a letter from the Italian drugmaker saying that it has decided to withdraw the application after concerns were raised by European officials over how the clinical trials were designed.

The company had said that it expected to get approval to sell Opaxio, a drug to treat the most common type of lung cancer, by early 2011. [ID:nL7187530]

(Reporting by Ben Deighton; editing by Elaine Hardcastle)

 

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