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Today, Prilenia announced that, as planned, they have submitted the Marketing Authorization Application (MAA) to the European Medicines Agency (EMA) for Pridopidine. Pridopidine is the investigational treatment for Huntington’s disease (HD) for which we had updates last April that we shared in this blog post.
And what exactly is a Marketing Authorization Application? In simple terms, it’s a formal request that a company makes to the EMA, asking for permission to sell a new drug in all European Union (EU) Member States, Iceland, Norway and Liechtenstein. This application includes all the scientific data, clinical trial results, and safety information about the drug. Basically, the EMA reviews all this information to decide whether the drug is safe and effective enough to be available to patients.
We are very hopeful about this news, since it’s an important step towards the possible availability of this treatment in Europe. But, it is also important to remember that Pridopidine is still in the research phase and has not been approved by any health authority, who are the responsible entities for ensuring the efficacy, safety and high quality of medicines to protect public health.
The review process of the marketing authorization application by the EMA usually takes between 12 and 14 months, during this period the EMA will evaluate all the documents and data submitted by Prilenia, which includes more than 500,000 pages to be reviewed.
It is crucial to understand that the approval of this application does not mean that the drug will be immediately available to patients.
If approved, the availability of the drug in Europe may vary from country to country. After approval, additional evaluations by the regulatory agencies in each country are required, as well as the establishment of a system for financing and access to the drug, which may imply that the access timeline may be different in each European country.
While we are aware that Pridopidine still has a journey to make within the regulatory agencies, we also recognize that this is great news, since this is the first time that a drug has been submitted to the EMA as a specific treatment for Huntington’s disease.
We would especially like to thank all the patients, families and healthcare professionals who have been part of this study, as this step forward by Prilenia would not have been possible without you.
Community Letter and Press Release
Find here the letter that Prilenia has prepared for the Huntington’s community regarding this update, and the press release they have published.
– Article written by Jarelys López