Alzheimer’s drug heads to phase III as EMA approves phase III study

Biogen’s antibody drug for Alzheimer’s has gone into phase III after the European Medicines Agency told the US drugmaker to finish the study.

Alzheimer’s disease affects around 37 million people worldwide, according to the World Health Organisation. To date, there are no current approved treatments that prevent or delay progression of the disease.

US company Biogen said the study testing its drug aducanumab was completed on 9 September, suggesting that the phase III trial could be launched shortly.

The phase III trial called Expedition 1 compared aducanumab to a placebo, and it showed in late-stage testing last year that patients taking the drug reduced their level of beta amyloid protein, the hallmark of the disease, by more than 70% compared with the placebo group.

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AD is caused by plaques and tangles of amyloid-beta protein, building up on a nerve cell’s surface. Making the protein can lead to neuronal damage. There is no current cure for the disease, and treatment is targeting reducing the size of the plaques.

The US Food and Drug Administration is currently reviewing the drug, and some analysts have suggested the EMA review could happen around the same time.

The drug is made by a Biogen subsidiary called Alnylam, which is based in Massachusetts.

Aducanumab is Biogen’s third attempt to win approval for the Alzheimer’s treatment, following two earlier failures. This year, the EMA asked Biogen to clarify certain elements of the data presented by Dr Alessandro Acquisti at the European Association for the Study of the Ageing.

Acquisti presented data from a study of 192 people with mild-to-moderate Alzheimer’s who are at very high risk of disease progression, where people taking the treatment had beta amyloid levels 35-45% lower than the placebo group.

Biogen said the responses in this case were consistent with the overall results of the study. The company submitted responses to the review and the EMA has recently accepted them as satisfactory, Biogen said.

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