Italian regulators have cleared Cambridge Laboratories’ Xenazina for the treatment of movement disorders associated with Huntington's disease and moderate-to-severe tardive dyskinesia.
Approval of Xenazina (tetrabenazine) – launched in the UK as Xenazine and as Nitoman in Germany - was secured by the company’s partner Chiesi Farmaceutici S.p.A, after it bought exclusive Italian distribution rights to the drug in 2003.
Commenting on the news, Mark Evans, Cambridge Labs’ chief executive, said: "The approval of Xenazina in Italy, the third major territory in the roll-out of Xenazine, is a further success for Cambridge. In Chiesi we have an internationally renowned partner who strengthens our commercial expertise."
First for chorea
According to the company, Xenazine, which works by preventing over-activity of the neurotransmitter dopamine, is the first product filed in the USA for treatment of chorea associated with Huntington's disease. Chorea is a debilitating symptom of a number of neurological diseases involving excessive, involuntary, and repetitive movements of the face, limbs, or entire body.
Clearance of the drug was based, in part, on the results of an 84-patient Phase III trial, published in February 2006 in the journal Neurology, which showed that it significantly cut patients' chorea burden without causing many of the side effects observed with other therapies, Cambridge Labs said.