European Medicines Agency rejects AB Science’s ALS Drug

Science

European Medicines Agency advisors have rejected approval of masitinib for amyotrophic lateral sclerosis, due to the data provided not being robust enough.

It also failed to recognise the clinical relevance of the distinction made between patients with a ‘normal’ progression and patients where an improvement on the primary endpoint was demonstrated.

“European Medicines Agency advisors have rejected approval of masitinib for amyotrophic lateral sclerosis, due to the data provided not being robust enough.“

The company has requested a re-examination of the decision to be made and have said that they will provide further analyses to address any concerns.

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