H. Lundbeck A/S' (Lundbeck) partner Teva Phamaceuticals Industries Ltd. (Teva) announced that results from the ADAGIO trial, published online in The New England Journal of Medicine, demonstrated that Parkinson's disease patients receiving Azilect® (rasagiline) 1mg/day at the start of the study (early-start group) experienced superior benefit over 18 months compared with those who started the exact same treatment nine months later (delayed-start group)(1). This finding is consistent with a possible disease-modifying effect for Azilect® 1 mg/day.
Professor C. Warren Olanow, MD, Department of Neurology, Mount Sinai School of Medicine, New York and co-principal investigator of the ADAGIO study, commented, "A therapy that slows or stops disease progression is the greatest unmet need in the treatment of patients with Parkinson's disease. Current therapies do not prevent the development of disability in such patients. The results of the ADAGIO study provide support for the possibility that early treatment with Azilect® 1 mg/day may slow the development of disability."
Azilect® is the first Parkinson's disease treatment to succeed in a prospective delayed-start study, a trial design specifically developed to test for the possibility of a disease-modifying effect.
Professor Olivier Rascol, Department of Clinical Pharmacology, University Hospital, Toulouse, France and ADAGIO co-principal investigator, stated, "The results of the ADAGIO study provide novel data to support the use of Azilect® 1 mg daily as initial treatment of patients with Parkinson's disease. The ADAGIO study, which utilized a novel trial design with three primary endpoints, suggests that the drug has a positive impact on slowing the progression of patients' disability, beyond its already known symptomatic benefit."
The content of this release will have no influence on the Lundbeck Group's financial result for 2009.
About ADAGIO
ADAGIO (Attenuation of Disease progression with Azilect® Given Once-daily) was a randomized, multi-center, double-blind, placebo-controlled, parallel-group study prospectively examining rasagiline's potential disease-modifying effects in 1,176 patients with early, untreated Parkinson's disease. Patients from 129 centers in 14 countries participated and were randomized to initiate treatment for 72 weeks with rasagiline 1 mg/day or 2 mg/day, or to initiate treatment for 36 weeks with a placebo followed by 36 weeks with rasagiline 1 mg/day or 2 mg/day.
The primary analysis included three hierarchical endpoints based on total scores in the Unified Parkinson's Disease Rating Scale (UPDRS). Azilect® 1 mg/day early-start met all endpoints of the primary analysis: less deterioration in UPDRS score than placebo between weeks 12 and 36; less worsening than delayed-start in UPDRS score in comparing change between baseline and week 72 despite being on the same medication for the last 9 months; and non-inferiority to delayed-start in rate of deterioration between weeks 48 and 72. The ADAGIO study also confirmed the positive symptomatic effect and safety profile of Azilect®, in line with prior studies(2).
About Azilect®
Azilect® (rasagiline) 1 mg tablets are indicated for the treatment of the signs and symptoms of Parkinson's disease both as initial therapy alone and to be added to levodopa later in the disease. Azilect® 1 mg tablets are now available in 38 countries, including the U.S., Canada, Israel, Mexico and all of the European Union countries, where it is marketed by Teva in collaboration with Lundbeck as part of a long-term strategic alliance.
About Parkinson's disease
Parkinson's disease is an age-related degenerative disorder of the brain. Symptoms can include tremor, stiffness, slowness of movement and impaired balance. An estimated four million people worldwide suffer from the disease, which usually affects people over the age of 60.
1. Olanow CW et al. A double-blind delayed start trial of rasagiline in Parkinson's disease. NEJM 2009
2. Parkinson Study Group. A controlled trial of rasagiline in early Parkinson's disease. Arch Neurol 2002;59:1937-1943