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Parliamentary questions
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4 December 2017
Question for written answer P-007464-17
to the Commission
Rule 130
Soledad Cabezón Ruiz (S&D)

 Subject:  Evaluation procedure for Aplidin
 Answer in writing 

PharmaMar submitted an application in October 2016 for a marketing authorisation for Aplidin, the approval of which would make it the only European company with a medicinal product against multiple myeloma.

According to the preliminary assessment of the CHMP of the EMA, a negative opinion on the granting of such request is expected, in spite of the fact that the phase III test — known as ADMYRE and which formed the basis for the application — had been given ‘Protocol Assistance’ by the EMA prior to its start and had fulfilled the main objective of the test in a statistically significant manner (p = 0.0054). Moreover, the last report by the rapporteur and co-rapporteur, received on 31 October, did not indicate any objection and suggested that the opinion could be favourable.

The company was invited to attend a hearing on 7 November with the CHMP — without being given prior information on the subject to be discussed — which focused on the statistical methodology for the secondary objective of the study, which had previously been accepted by the evaluators, with the EMA informing it verbally that the CHMP was tending towards a negative vote.

In addition, the company has drawn our attention to other irregularities in the procedure, and to the possible interest of other non-European pharmaceutical companies in preventing PharmaMar from being given authorisation for Aplidin.

Given that the final result of the evaluation is expected between 11 and 15 December, what does the Commission intend to do to shed light on the matter and to ensure an objective and transparent procedure?


(1)This question is supported by Members other than the author: Inmaculada Rodríguez-Piñero Fernández (S&D), José Blanco López (S&D).

Original language of question: ES 
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