BRIEF—EMA re-affirms non-renewal of masitinib and Translarna authorizations

Following a re-examination, the European Medicines Agency’s human health committee, CHMP confirmed its initial recommendation to refuse the granting of a conditional marketing authorization for Masitinib AB Science’s masitinib.

This medicine was intended for the treatment of amyotrophic lateral sclerosis (ALS), a progressive disease of the nervous system, where nerve cells in the brain and spinal cord that control voluntary movement gradually deteriorate, causing loss of muscle function and paralysis.

The committee also confirmed its previous recommendation to not renew the conditional marketing authorization for PTC Therapeutics (Nasdaq: PTCT) Translarna (ataluren).