CHMP rebuffs AB Science’s masitinib in ALS

EMA’s CHMP recommended against approval of masitinib (AB1010) from AB Science S.A. (Euronext:AB) to treat amyotrophic lateral sclerosis. The company said it plans to address the issues raised by the committee and expects a second opinion in July.

According to AB Science, the agency said data from Good Clinical Practice inspections at two of the main trial sites were not reliable or robust enough to support approval. The agency noted the possibility of bias caused by including early dropouts in the analysis of the primary endpoint of ALS Functional Rating Scale (ALSFRS) score. The committee also did not recognize the clinical relevance of distinguishing between normally progressing and rapidly progressing patients for the primary endpoint...