Bayer Files For Metrifonate Approval In EU, Then USA

Bayer AG has filed with the European Medicines Evaluation Agency forpan-European approval to market metrifonate, its acetylcholinesterase inhibitor for the treatment of mild-to-moderate Alzheimer's disease. The company says that metrifonate will also be filed with the US Food and Drug Administration within the next week or so.

The drug, if approved, will join Pfizer/ Eisai's Aricept (donepezil) and Novartis' Exelon (rivastigmin) in a highly-competitive market. Metrifonate differs, according to the company, in that it is an inactive prodrug which is transformed to an active metabolite over a number of hours, giving a long duration of action.

This gradual effect plays a role in its tolerability, Bayer points out, permitting once-daily dosing without the need for titration, unlike Aricept and Exelon. Furthermore, as it has low protein binding and is not metabolized via the liver cytochrome system, it has a very low potential for drug/drug interaction, a feature important to the elderly who may be taking other medications.