Application for marketing authority for Pridopidine to treat Huntington’s disease – community letter from Prilenia

Dear Huntington’s Disease Community,

We recently have had meetings with regulatory authorities in the European Union about next steps for our HD program. We are pleased to let you know that after positive and constructive feedback, we plan to submit a Marketing Authorization Application (MAA) for pridopidine for the treatment of Huntington’s disease (HD) to the European Medicines Agency’s (EMA) Committee for Medicinal Products for Human Use (CHMP). An MAA is submitted for approval to market a medicine in European Union member countries. Submission is planned for mid-2024.

In our PROOF-HD study, pridopidine demonstrated consistent treatment benefits across independent measures that are most important to patients and families, including day to day function, cognition, motor, and clinical progression of HD. These benefits are especially compelling in patients not taking antidopaminergics (medicines to treat chorea and/or neuroleptics). In clinical studies to date, pridopidine was well-tolerated with no serious treatment-related adverse events, with a safety and tolerability profile similar to placebo.

The support from regulators to submit an MAA is an important step towards making new treatments accessible for patients with Huntington’s disease. Prilenia will have discussions with the U.S. Food and Drug Administration (FDA) about a potential path forward for pridopidine as a treatment option for those living with HD in the United States.

To learn more about this news and pridopidine, please read our press release here.

We will continue moving with urgency on behalf of the many families affected by HD around the world. We thank you for your commitment and collaboration as we move one step closer to providing a potential treatment option to the HD community.


Seth Rotberg, Senior Manager of Patient Advocacy and Engagement On behalf of the team at Prilenia


Full information and Q&As can be found here.

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