Prilenia plans to submit Marketing Authorisation Application in the EU for Pridopidine in Huntington’s disease.

If granted this means the drug will be the first drug specifically developed to target symptoms of Huntington’s disease, including that of cognitive impairment. Other potential benefits of the drug as found in the PROOF - HD study are detailed in the letter to the community. 

An application to the European Medicines Agency (EMA) means that their experts evaluate the findings presented by Prilenia to decide if they think the drug achieves the desired result. This process can take up to one year from the date of submission (mid-2024).

If the application to the EMA is successful Prilenia will then negotiate with each country on market access and pricing. In the UK this is the Medicines and Healthcare products Regulatory Agency (MHRA). If the EU approval is granted it is expected it will take another three to four months for a UK approval.

What is Pridopidine?

Pridopidine (45 mg twice daily) is an oral, highly selective and potent investigational S1R agonist that has exhibited a safety and tolerability profile similar to placebo in clinical studies to date. The S1R protein is highly expressed in the brain and spinal cord where it regulates several key processes that are commonly impaired in various neurodegenerative diseases. Activation of the S1R by pridopidine stimulates multiple cellular pathways, including autophagy, axonal transport, mitochondrial energy production, and calcium homeostasis which are essential to neuronal function and survival and may lead to neuroprotective effects. It particularly impacts cognition.

Pridopidine was the drug used as part of the Proof HD Trial.

What is Marketing Authorisation?

Marketing authorisation is the process of reviewing and assessing the evidence to support a medicinal product, in relation to its marketing, finalised by granting of a licence to be sold. This process can take up to a year. If granted Pridopidine will be available as a treatment for Huntington’s disease.  

Cath Stanley, Chief Executive of the Huntington’s Disease Association said,

“We welcome the news that a new drug treatment for Huntington’s disease has progressed to the stage of seeking approval from the EMA. This new treatment is a huge step forward in tackling one of the many symptoms of Huntington’s disease. However, there is still a way to go until we know whether approval will be granted and if it is when the drug will be available to people in the UK. We will keep you updated on the progress of the drug. Thank you to Prilenia for keeping the community informed.” 

From Prilenia:

Read the press release

Read the letter to the community