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Joint Statement by Six Parkinson’s Disease Organizations Regarding Proposed Label Change for Azilect

Joint Statement by Six Parkinson’s Disease Organizations Regarding Proposed Label Change for Azilect

FDA Advisory Committee Meeting

This statement is prepared on behalf of the American Parkinson Disease Association, The Michael J. Fox Foundation for Parkinson’s Research, the National Parkinson Foundation, the Parkinson’s Action Network, the Parkinson Alliance, and the Parkinson’s Disease Foundation. Together we represent a large segment of the Parkinson’s disease community and, on behalf of that community, we thank the Food and Drug Administration for holding today’s meeting of the Advisory Committee to address the Teva Pharmaceutical application for a labeling of Azilect as a therapy that slows the clinical progression of Parkinson’s disease. As a community, when it comes to finding new ways of confronting Parkinson’s disease, we are fiercely pro-investment, pro-progress and pro-development.

- We are all dedicated to the development of critically needed new and transformative treatments for people with this devastating disease.

- Each one of us has welcomed the achievement of each milestone in the development of new therapies, from Levodopa in the 1960s, to dopamine agonists and improved surgical approaches in the 1990s, and to MAOB inhibitors, such as Azilect, in the 2000s.

- All of us support the concept of partnering with industry to invest directly in the process of drug development.

Furthermore, we believe that the distinction between a treatment that slows the clinical progression of the disease and a true disease-modifying treatment requires elucidation, as the subtle yet significant difference between the two is likely to cause confusion and artificially raise expectations of general practitioners and people with Parkinson’s disease.  This is especially true given that Azilect is a therapy that has already been approved by the FDA as a symptomatic treatment for Parkinson’s disease. Finally, we wish to express our community’s hope that the FDA, in evaluating this application, will use the opportunity to provide needed clarity to the pharmaceutical industry by detailing the requirements that will need to be met to demonstrate success for a disease-modifying therapy in Parkinson’s disease.  Such action will remove one aspect of uncertainty in the business decisions that must be made in developing the new treatments that will benefit those people who live with this disease and are most affected by its unrelenting progression.

Thank you for your attention.

Joel Gerstel, President & CEO

American Parkinson Disease Association

Todd Sherer, Ph.D., CEO

The Michael J. Fox Foundation for Parkinson’s Research

Joyce A. Oberdorf, President and CEO

National Parkinson Foundation

Amy Comstock Rick, J.D., CEO

Parkinson’s Action Network

Carol J. Walton, CEO

The Parkinson Alliance

Robin Anthony Elliott, Executive Director

Parkinson’s Disease Foundation

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