Le Lézard
Classified in: Health
Subject: TRI

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


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News published on 3 january 2018 at 07:36 and distributed by: