Israel-headquartered Teva’s Azilect (rasagiline tablets) is approved for use as initial monotherapy in early Parkinson’s disease and as adjunct therapy to levodopa in moderate to advanced disease. The drug is expected to become available in Canada this September.
The approval was based on data from three large, multicenter, double-blind, randomized, placebo-controlled clinical studies. These studies in over 1,500 patients demonstrated that Azilect given once daily was effective, and well-tolerated, given as initial monotherapy in the early stages of Parkinson’s disease or when added to levodopa and other therapies in more advanced stages of the disease.
Azilect’s development is part of a long-term alliance for co-development in Parkinson’s disease and European marketing between Teva and H Lundbeck A/S.
To date, Azilect, has been made available in 19 countries – most recently the US, in July.
In other announcements, Teva Neuroscience reported having enrolled the first patient in a study to evaluate the impact of regular neutralizing antibody, or NAb, testing on multiple sclerosis treatment patterns. This study, the largest of its kind, will examine changes in the treatment management of tested and non tested patients receiving a high-dose interferon.