Posted by Michael Wonder on 23 Apr 2018
AB Science announces that the CHMP has adopted a negative opinion for the marketing authorization of masitinib in amyotrophic lateral sclerosis
19 April 2018 - AB Science will provide additional data through a re-examination procedure.
AB Science announces that the CHMP of the EMA has adopted a negative opinion for the marketing authorisation of masitinib in the treatment of adult patients with amyotrophic lateral sclerosis.
The grounds for this negative opinion are:
• The CHMP considered, based on a Good Clinical Practice inspection carried out on two of the main clinical investigation centers of the study, that the reliability of the data was not robust enough to support a registration.
• The CHMP did not recognize the clinical relevance of the distinction made by AB Science between patients with "normal" progression (accounting for 85% of patients in the study) and for whom an improvement on the primary endpoint - ALSFRS score - has been demonstrated, and those with "rapid" progression (accounting for 15% of patients in the study).
• The CHMP considered that the primary analysis of the ALSFRS score for patients who stopped the study prematurely, based on the LOCF method (last observation carried forward), could introduce a bias in the analysis of the results.
