PharmaMar has Requested the Process of Re-Examination for AplidinŽ from the EMA

Wednesday, January 3, 2018 Drug News
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MADRID, January 3, 2018 /PRNewswire/ --

PharmaMar (MCE: PHM) has announced the initiation of the re-examination process

by the European Medicines Agency (EMA) for AplidinŽ (plitidepsin) for the indication of relapsed and refractory multiple myeloma.

     (Logo: http://photos.prnewswire.com/prnh/20150203/727958-b )

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 AplidinŽ (plitidepsin), which could arrive around June or July, 2018.

Media Relations (+34-6387-96215) and Investor Relations (+34-9144-44500)

SOURCE PharmaMar

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