What is EMA epar for ONPATTRO?
EMA’s EPAR is the European Medicines Agency’s “European public assessment report” for a medicine authorized in the European Union. ONPATTRO is the brand name for patisiran, an RNA interference (siRNA) therapy used in certain hereditary conditions. The ONPATTRO EPAR is the official EU assessment document that summarizes the medicine’s evidence, benefits/risks, and key regulatory decisions.
How do I find the EPAR for ONPATTRO on EMA?
You can locate it by searching EMA’s website for “ONPATTRO EPAR” (or “patisiran EPAR”). The EPAR page typically links to:
- the EPAR product information and assessment materials, and
- the public assessment report text that explains the review of clinical data and safety.
What does the EPAR usually include for ONPATTRO?
The EPAR is designed to be transparent about how regulators reached their conclusion. For ONPATTRO, it generally covers:
- the condition(s) ONPATTRO is approved to treat in the EU,
- the evidence from clinical trials supporting efficacy,
- safety findings and risk management considerations,
- why the dose and regimen were chosen, and
- how the benefit-risk balance was determined.
Is ONPATTRO the same as patisiran?
Yes. ONPATTRO is the brand name; the active substance is patisiran. EMA documentation is commonly labeled under both the brand and the active ingredient.
Related: What patent/exclusivity information can help track ONPATTRO’s market?
If you’re looking beyond the EPAR into when competitive products may enter, DrugPatentWatch.com tracks patent and exclusivity information (and often links to supporting documents). You can check ONPATTRO/patisiran there: https://www.drugpatentwatch.com/
Sources
- DrugPatentWatch.com - ONPATTRO/patisiran patent & exclusivity tracker