CHMP Issues Negative Opinion for Masitinib Marketing Authorization for ALS
The European Medicines Agency's (EMA) Committee for Medicinal Products for Human Use (CHMP) has adopted a negative opinion regarding the marketing authorization of AB Science's masitinib for the treatment of Amyotrophic Lateral Sclerosis (ALS).
AB Science announced on Thursday that the European Medicines Agency's (EMA) Committee for Medicinal Products for Human Use (CHMP) has recommended against granting marketing authorization for masitinib as a treatment for Amyotrophic Lateral Sclerosis (ALS). The decision follows the committee's assessment of the drug's efficacy and safety profile.
Masitinib is a drug candidate developed by AB Science, targeting multiple inflammatory and neurodegenerative pathways. The company had sought EU marketing approval for masitinib in ALS patients, aiming to provide a new therapeutic option for this severe and progressive neurological disease.
The CHMP's negative opinion signifies that the regulatory body does not recommend the drug's approval for the EU market at this time. AB Science stated that it is currently reviewing its options in light of this outcome. The company has previously faced hurdles in obtaining regulatory approval for masitinib in other indications.
Amyotrophic Lateral Sclerosis is a rare neurodegenerative disease that affects motor neurons, leading to muscle weakness and paralysis. There is currently no cure for ALS, and existing treatments focus on slowing disease progression and managing symptoms.