Hayward, Calif.-based Aradigm Corp. is seeking EU approval for a drug to treat patients with a certain respiratory disease.
The specialty pharmaceuticals company filed a marketing authorization application with the European Medicines Agency, seeking approval for Linhaliq to treat non-cystic fibrosis bronchiectasis in patients with a chronic lung infection.
The application is supported by results from two phase 3 trials.
Non-cystic fibrosis bronchiectasis is a rare, severe and chronic disease where a patient's airways are abnormally widened due to inflammation and lung infection.
In January, the drug was rejected by the U.S. Food and Drug Administration for treating the same group of patients. The regulator said at the time that it could not approve the company's application without a verification of the company's results from a late-stage trial from an independent third party.
