Ebixa (memantine) approved for the treatment of moderate Alzheimer’s disease

Ebixa extends its indication to become the only drug for moderate and severe Alzheimer’s disease.

The Committee for Medicinal Products for Human Use (CHMP) announced late last night its decision to extend Ebixa’s current indication (moderately severe to severe disease) to include moderate stages of Alzheimer’s disease (AD). Upon implementation of this approval by the European Union Commission, Ebixa will become the first Alzheimer’s drug in Europe to cover the moderate to severe stages of the disease.

In meta-analyses from six international phase III placebo-controlled six-month studies, patients with moderate to severe Alzheimer’s disease (MMSE total score at baseline below 20) showed statistically significant effect in favour of memantine treatment for the cognitive, global, and functional domains. Further analysis showed that twice as many memantine-treated patients showed a statistically significant benefit in preventing marked clinical worsening in all three domains as compared to placebo-treated patients.

“This is an excellent step forward for patients with Alzheimer’s disease”, said Professor Roy Jones, Director of the Research Institute for the Care of the Elderly, Bath, United Kingdom. “Ebixa has shown significant benefits in moderate to severe Alzheimer’s disease and it is at the moderate stage when most patients are currently diagnosed”.

Ebixa has also proven effective in reducing some of the core and most distressing symptoms of AD. Study results have demonstrated that Ebixa-treated patients experienced significant benefits in memory, language and the ability to perform daily activities. Furthermore, Ebixa has proven effective in significantly reducing levels of agitation/aggression, delusions and irritability in patients with AD.

The progression of Alzheimer’s disease is classified according to mild, moderate and severe stages. Moderate to severe disease, when symptoms become more apparent, is estimated to affect 80%(i) of diagnosed Alzheimer’s patients. This significant proportion of Alzheimer’s patients will now have access to this efficacious treatment for Alzheimer’s disease.