PharmaMar Has Requested the Process of Re-Examination for Aplidin From the EMA
MADRID, January 3, 2018 /PRNewswire/ --
PharmaMar (MCE: PHM) has announced the initiation of the re-examination process by the European Medicines Agency (EMA) for Aplidin(R) (plitidepsin) for the indication of relapsed and refractory multiple myeloma.
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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(R) (plitidepsin), which could arrive around June or July, 2018.
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