EMA Evaluates Biohaven's Troriluzole, Which FDA Refused to Evaluate

The EMA (a regulatory agency similar to Europe's ANVISA) began evaluating on October 26th the American pharmaceutical company Biohaven's drug Troriluzole for SCA3 ataxia, which the FDA had refused to evaluate. The FDA's refusal sparked a worldwide mobilization organized by the NAF (National Ataxia Foundation), with the participation of Abahe in Brazil.

The EMA has up to 210 working days (approximately a year) to issue its opinion. If the EMA approves Troriluzole, the drug's marketing in Europe will still need to be approved by the European Commission, which could take another 67 days.

Even if approved in Europe, the drug can only be sold in Brazil after approval by ANVISA.

Let's hope so! If the EMA approves, Trorilu could be the first drug approved in the world to slow the progression of SCA3 ataxia.

Original report (Nuno Ricardo Alves)

Thank you for your follow up query about the medicine troriluzole.

We confirm that on 26 October 2023 EMA has started evaluating this medicine, which is now included in the 'list of medicines under evaluation': https://www.ema.europa.eu/en/medicines/medicines-human-use-under-evaluation

Medicines for human use under evaluation - European Agency

Medicines for human use under evaluation

www.ema.europa.eu

Once an application for marketing authorization has been submitted to EMA, EU legislation requires the evaluation process to take no more than 210 'active days'. The active days are counted as calendar days during this period.

However, during the evaluation, EMA's human medicines committee (CHMP) will look at the evidence presented by the medicine developer and produce a list of questions or outstanding issues. The assessment will then be paused while the developer generates responses to these, and the length of the pause (called 'clock stop') that the developer asks for will depend on the number and complexity of the concerns. This can happen more than once, making the prediction of the date of a final opinion tricky. Once the process concludes, EMA will publish a statement on its website in the monthly CHMP highlights.

Please also note that the conclusion of an evaluation will not be the final step in making a medicine available to healthcare professionals and patients in the EU. Should the Agency come to a positive opinion, this has to be sent to the European Commission, the body with the legal authority to issue a marketing authorization throughout the EU, which will issue its opinion within 67 days, formally concluding the process. It is then up to the company to decide on its plans for marketing and reimbursement in individual countries, in consultation with the relevant national authorities.

We hope you find the above information useful.

[Post published on 10/11/2023 by Márcio Galvão]