German drug developer 4SC has announced that resminostat, a drug for the treatment of hepatocellular carcinoma – the most common form of liver cancer – has been recommended for approval by the European Medicines Agency .
The recommendation has been forwarded to the EU commission for the final approval and publication in the community register.
The news follows the recent orphan drug designation granted by the US Food and Drug Administration for the same programme.
4SC CEO Ulrich Dauer said that both designations “emphasise the importance of developing novel therapies in this indication in order to provide effective treatment options to patients suffering from this life-threatening disease”.
The European Medicines Agency ‘s orphan medicinal product designation includes a ten-year period of market exclusivity from the date of approval for drugs and biologics that address rare diseases that affect no more than five in 10,000 people in the EU.