Madrid, Spain (Press Release) – PharmaMar (MCE: PHM) has announced the initiation of the re-examination process by the European Medicines Agency (EMA) for Aplidin® (plitidepsin) for the indi­ca­tion of re­lapsed and refractory multiple myeloma.

PharmaMar believes that this novel molecule could become part of the thera­peutic arsenal avail­able for the treat­ment of multiple myeloma in Europe.

It is worth noting that the re-examination procedure is handled by the EMA´s CHMP and usually lasts around 4 months. It concludes with either the con­firmation of the negative opinion or with the issuing of a new positive opinion by the CHMP.

After finalizing this process of re-examination, the European Com­mis­sion will be in charge of emitting the final verdict on the Marketing Authorization Application (MAA) for Aplidin® (plitidepsin), which could arrive around June or July, 2018.

Source: PharmaMar.