Drug Overview
Azilect (Teva/Lundbeck/Takeda) contains the pure R-isomer of rasagiline and acts as a selective irreversible monoamine oxidase inhibitor (MAOI), with up to 10 times more potency than selegiline and without metabolizing into amphetamine derivatives. Azilect prolongs the activity of dopamine in the brain to restore a measure of normal locomotion, gait, and coordination.
Azilect was approved in Europe in February 2005 and in the US in May 2006 for the treatment of Parkinson’s disease, as a monotherapy in early-stage patients and as an adjunctive treatment to levodopa in moderate to advanced disease. In June 2014, the drug was approved in the US as an adjunct to dopamine agonists on the basis of the ANDANTE (Add On to Dopamine Agonists in the Treatment of Parkinson’s Disease) trial. Azilect is marketed by Teva and Lundbeck, with the partnership providing Lundbeck a license spanning Europe and certain Asian countries. Lundbeck transferred sales rights in Europe back to Teva during 2016 upon the availability of the first generics. In Japan, Teva has a separate agreement with Takeda for the drug’s commercialization, and it was filed for regulatory approval in June 2017.
CONTENTS
4 OVERVIEW
4 Drug Overview
5 Product Profiles
5 Azilect : Parkinson’s disease
LIST OF FIGURES
9 Figure 1: Azilect for Parkinson’s disease – SWOT analysis
10 Figure 2: Datamonitor Healthcare’s drug assessment summary of Azilect for Parkinson’s disease
11 Figure 3: Datamonitor Healthcare’s drug assessment summary of Azilect for Parkinson’s disease
13 Figure 4: Azilect sales for Parkinson’s disease across the US, Japan, and five major EU markets, by country, 2016–25
LIST OF TABLES
6 Table 1: Azilect drug profile
7 Table 2: Azilect pivotal trial data in Parkinson’s disease
14 Table 3: Azilect sales for Parkinson’s disease across the US, Japan, and five major EU markets, by country ($m), 2016–25