Breaking News

Prilenia will ask for market approval at the EMA

Today, Prilenia made a groundbreaking announcement, revealing that they are going to apply for market authorization at the European Medicines Agency (EMA) within the next few months. This marks a historic moment as the first-ever medicine for Huntington’s Disease (HD) reaches this critical stage.

Throughout a press release, Prilenia explains their plans to submit the Marketing Authorization Application for Pridopidine (an oral drug) on Huntington’s Disease.

As Dr. Michael R. Hayden, CEO of Prilenia, said in the press release: “Pridopidine demonstrates consistent treatment benefits across independent measures that are important to patients and families. These measures include day-to-day function, cognition, motor and clinical progression in people living with HD. The benefits are clearly evident in those with HD who are not taking anti-dopaminergic medications (ADM).

Astri Arnesen, President of the European Huntington Association (EHA), expressed joy for the global HD community, stating, “This is a day to celebrate! Prilenia, having diligently worked with the data since last year, has decided to seek market authorization with the EMA. Following the mixed results from the April 2023 PROOF-HD study, today’s announcement is genuinely fantastic news.

However, it’s essential to highlight three crucial points:

  1. Pridopidine is not a cure: The results suggest a slowing of disease progression.
  2. The review of the application takes time and EMA can say NO
  3. If EMA says YES – it will take time before the medicine is available and paid for by health insurance entities 

Submitting an application to the EMA means that their experts will rigorously evaluate Prilenia’s findings, determining if the results convincingly demonstrate efficacy and improvement for patients. EMA focuses on two primary factors: the medicine’s safety and its positive impact on patients. This process may take up to a year. If the answer is positive on both fronts, market authorization will be granted, allowing the product to be sold in the EU, Norway, Iceland, and Lichtenstein.

However, this is not the end of the journey. Prilenia, if granted market authorization, will need to navigate negotiations with authorities in each country regarding market access and pricing. The pivotal question arises: Who should bear the cost of the treatment and to what cost?

Upcoming webinar: Prilenia filing for EMA approval for Pridopidine – what does this mean for patients?

UPCOMING WEBINAR: Prilenia filing for EMA approval for Pridopidine – what does this mean for patients?

The European Huntington Association, in close cooperation with Prilenia, decided to organize a webinar on March 18th at 6pm CET to better understand this news and create a space for the  Huntington’s community to learn, share their thoughts and ask questions. Register now and use this opportunity to learn in a family-friendly language about Prilenia’s news.

Henk Schuring, Chief Regulatory & Commercialization Officer at Prilenia, will shed light on the rationale behind this decision and the process leading up to it. What factors influenced their decision?

Anne Rosser, Professor from Cardiff University, will discuss the significance of this major step for patients and families. She will share her insights on how we should perceive the opportunities presented and the precautions we should bear in mind. Following the presentations, there will be a dedicated time for questions and discussions.