Teva and Lundbeck are starting the European launch of Azilect/Agilect (rasagiline), their new, once-daily treatment for Parkinson’s disease. Azilect 1mg received approval from the European regulator in February [[23/02/05f]], and will be available this month in the UK, followed by roll-out in the rest of Europe [[19/11/04f]]. The drug has been submitted to the US Food and Drug Administration.
The UK is the only second country to launch Azilect. The drug first became available in Israel, where it was developed by Teva, after winning its first approval in this market early this year [[05/01/05g]]. Azilect is being marketed in Europe by Teva and Lundbeck as part of a long-term strategic alliance between the two companies.
Azilect 1mg is licensed either as monotherapy in early-stage PD, or as adjunct therapy to the gold-standard treatment, levodopa, in patients with moderate to late-stage disease. Based on results of the Phase III TEMPO study, early treatment with Azilect alone may not only control PD symptoms but may also slow disease progression in early-stage patients. This advantage for early compared to delayed initiation of Azilect continued in six-year follow-up from TEMPO, announced at the current International Congress on Parkinson’s Disease and Related Disorders in Berlin. Data showed the beneficial effects of early treatment over 12 months, and a mean decline in the unified Parkinson’s disease ratings scale of just two to three units for patients receiving Azilect, versus a decline of eight to 11 units for placebo receivers. The 404 patients included at entry in the placebo-controlled phase of the TEMPO study, had a mean UPDRS score of 25 units.
These findings await confirmation in a larger, delayed start‚ clinical trial, which will begin recruiting in September and is likely to report in 2009/10. In the meantime, Azilect’s once-daily dosing, lack of titration, and tolerability in patients of all ages are likely to give the drug a competitive advantage over other PD treatments such as dopamine agonists, which require careful dosing to reduce side-effects.