A EMA (agência regulatória tipo a ANVISA da Europa) começou a avaliar em 26 de Outubro o Medicamento Troriluzole da farmacêutica americana Biohaven para a ataxia SCA3, que a FDA se recusou a avaliar. A recusa da FDA causou mobilização mundial organizada pela NAF (National Ataxia Foundation), com participação da Abahe no Brasil.
A EMA tem prazo de até 210 dias úteis (um ano mais ou menos) para dar seu parecer. Se por acaso a EMA aprovar o Troriluzole ainda será necessário que a comercialização do remédio da Europa seja aprovada pela Comissão Europeia, o que pode levar mais 67 dias.
Mesmo se for aprovado na Europa, o medicamento só poderá ser comercializado no Brasil após a aprovação da ANVISA.
Vamos torcer! Se a EMA aprovar, o Trorilu pode ser o primeiro remédio aprovado no mundo para retardar a progressão a ataxia SCA3.
Informe original (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
Once an application for marketing authorisation 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 answers 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 authorisation 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 publicado em 10/11/2023 por Márcio Galvão]