CHMP does not recommend approval of Masican for amyotrophic lateral sclerosis.- AB Science.
The Committee for Medicinal Products for Human Use has rejected approval of Masican (masitinib) from AB Science for amyotrophic lateral sclerosis. According to the CHMP, the reliability of data provided in the submission did not support a registration, based on a Good Clinical Practice inspection at two of the main clinical study sites. The CHMP also said that the submission also failed to recognise the clinical relevance of the distinction between patients with "normal" progression and for whom an improvement on the primary endpoint has been shown, and those with �rapid" progression (accounting for 15 percent of patients in the study). Another decision from the CHMP is expected in July 2018.
Comment: The CHMP rejected accelerated approval for the drug in 2016.
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