VITAL pharmaceuticals will be placed on red alert in Europe following the discovery of an unapproved version of the drug for a rare form of brain cancer.
The European Medicines Agency said on Monday that the drug, known as VIMO, had been tested for the first time in Europe in a human trial in Greece and will be added to the European list of prohibited products under a directive from EU member states.
The agency did not say how long the trial was going to last.
It said the European Commission had not yet been given the results of the trial.
The discovery of the new version of VIMOSu is a setback for the company, which has been fighting for a recall of the device from the United States.VITAL has faced numerous legal and regulatory challenges in the US.
The company was sued by the National Institutes of Health over the VIMosu drug, which the company said was designed to treat patients with mild-to-moderate forms of the rare form, CTE, and was designed for people over the age of 50.
The company also had a fight with the FDA over its use of an ingredient called niacinamide.
The FDA said it would be investigating VITAL.
“The FDA is currently investigating the safety of the VITAL Pharmaceuticals’ VIMOSTAN ® in a trial with a limited population of individuals over age 50,” the agency said in a statement.
“Vital Pharmaceuticals is working diligently to provide an update on the status of its VIMOSEUR ® drug.”
It said the company was committed to the safety and efficacy of its product and was evaluating the risks of the use of the unapproved drug.
Vital has faced a series of legal and scientific challenges.
The FDA said on April 27 it would review the company’s decision to add the drug to the prohibited list.