CHMP rejects Acrescent (Lundbeck)/Balaxur (Merz) as a treatment for Alzheimers Disease

On 18 October 2012, the CHMP adopted a negative opinion, recommending the refusal of the marketing authorisation for the combination medicinal product memantine hydrochloride and donepezil hydrochloride, known as Acrescent from Lundbeck and Balaxur from Merz, intended for the treatment of moderate to moderately severe Alzheimer�s disease in patients who are already taking memantine and donepezil.

The Committee was concerned that the studies presented by the companies had negative results except for one main study, in which patients already taking donepezil performed better in cognitive tests and in daily living activities when memantine was added to donepezil treatment. However, due to the study design it did not demonstrate a clear benefit of the combination treatment, since it did not include a control arm for patients treated with memantine alone. The CHMP considered that the additional analyses provided by the companies did not satisfy these concerns.The Committee also noted that a published study did not show a significant improvement in patients taking the combination treatment when compared with memantine alone.