(AOF) – AB Science collapses 35.62% to 5.25 euros, the European Medicines Agency has adopted a negative opinion for the application for marketing authorization of masitinib in the treatment of sclerosis amyotrophic lateral syndrome in adults.
Also known as Charcot’s disease, it is a rare degenerative disease that causes progressive muscular atrophy and paralysis.
The European Medicines Agency has estimated that the reliability of the data is not robust enough to support a registration given the Good Clinical Practice Inspection conducted at two of the main clinical investigation centers in the study.
She also did not recognize the clinical relevance of the distinction made by AB Science between patients with “normal” progression (representing 85% of patients in the study) and for whom an improvement of the primary endpoint – ALSFRS score evaluating the progression of disability in this malady – was demonstrated, and those with a “rapid” progression (representing 15% of patients in the study).
“But it’s on the main category that masitinib showed an effect, the other patients having been excluded from the primary analysis,” says Oddo BHF, who speaks of a blow to AB Science.
The Agency finally considered that the primary analysis of the ALSFRS score for patients who had stopped the study prematurely could introduce a bias in the analysis of the results.
In order to resolve these objections, the pharmaceutical company will provide further analysis on each of these points in a review proceeding. The review of the file will lead the Agency to give a second opinion in July 2018.
Oddo BHF considered amyotrophic lateral sclerosis to be “the best (and probably the only chance) that AB Science will obtain the registration of masitinib”. “If even in such a case AB Science fails to convince, it is hard to imagine what indication will allow the product to be allowed,” concludes the analyst.
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