Takeda's Idebenone Filed In Germany

Takeda has made its first application outside Japan for Arzkat (idebenone), an acetylcholinesterase inhibitor, for the treatment of the symptoms of Alzheimer's disease. Idebenone has been available in Japan as Avan since November 1986 for the improvement of cerebral metabolism and psychiatric symptoms in Alzheimer's disease. Takeda hopes to launch idebenone in Germany in 1998.

The application for idebenone seeks approval for "the improvement of symptoms in patients with mild-to-moderate Alzheimer-type dementia." This indication is wider than in Japan, and Takeda says it also plans to redevelop the drug for the home market, in addition to seeking regulatory approvals in Europe, the USA and elsewhere. Clinical trials in these new markets are at the planning stage.

Takeda notes that idebenone has a longer duration of action than other acetylcholinesterase inhibitors, including Warner-Lambert's Cognex (tacrine), which is currently the only available drug treatment for Alzheimer's disease, although others are advancing through trials rapidly (see also page 19).