- 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.
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