US company Pharmion has called in the agency ahead of an expected launch across the UK and Europe in 2008.
The drug hit the headlines in the 1970s when it emerged that its use in treating sickness during pregnancy in the previous decade had resulted in birth defects. But following its withdrawal the drug has been found to be effective in treating leprosy and has been used unlicensed to treat multiple myeloma.
Clew MD Mary Hicks said: ‘The drug’s history is a challenge but less so than we expected. Pharmion is not trying to hide away from the name.’
Pharmion has applied for a licence and is currently awaiting a verdict from the European Agency for the Evaluation of Medicinal Products.