Aplidin to be re-evaluated by the EMA

Spanish drugmaker PharmaMar (MSE: PHM) has received a notification from the European Commission (EC) advising that it is revoking the refusal to grant a Marketing Authorization (MA) for Aplidin (plitidepsin) in multiple myeloma.

According to the communication, the EC has re-evaluated the criteria applied for the participation of experts in the administrative procedure for the MA of Aplidin, as well as the relevant European Medicines Agency (EMA) rules governing conflicts of interest, so that they can ensure the objective impartiality of these experts.

Therefore, PharmaMar said, the EC notes that one of the experts of the Scientific Advisory Group (SAG) involved in the development of a rival product, was allowed to participate in the MA procedure for Aplidin, in accordance with the EMA rules applicable at the time.