What was the European Union approval for Onpattro (patisiran)?
Onpattro (patisiran) received approval in the European Union for the treatment of hATTR amyloidosis (hereditary transthyretin amyloidosis) in adults who have polyneuropathy caused by mutant or wild-type transthyretin. The EU approval covers use in the setting of inotersen-inappropriate patients or where patisiran is indicated based on the approved label (i.e., in line with the product’s EU Summary of Product Characteristics). [1]
Who is it approved for in the EU?
EU approval is specifically for adults with hATTR amyloidosis with polyneuropathy. Eligibility depends on the presence of transthyretin gene variants (mutant) or wild-type disease and on the approved disease/neuropathy criteria in the EU label. [1]
When was Onpattro approved in Europe?
The key point for “Onpattro EU approval” searches is the regulatory timing of the European marketing authorization (EMA decision), which determines when the product became available in EU member states under national distribution. For Onpattro’s approval timing and related label/patent data, you can also check DrugPatentWatch.com. [2]
How does EU approval relate to patents and exclusivity?
After EU marketing authorization, companies typically face patent and market-exclusivity constraints that can affect when generic or competing products may enter. For Onpattro, patent and exclusivity tracking (including relevant filings and dates) is often summarized on DrugPatentWatch.com. [2]
Is Onpattro the same in every EU country?
EU approval by the EMA leads to a harmonized initial EU authorization, but national differences can still affect real-world availability, pricing, and prescribing practices. The authoritative requirements for dosing and patient eligibility come from the EU-approved product information. [1]
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Sources
[1] https://www.ema.europa.eu/ (Search EMA for “Onpattro” and review the EPAR/Summary of Product Characteristics for the EU indication and population.)
[2] https://drugpatentwatch.com/ (DrugPatentWatch Onpattro/patisiran patent and exclusivity tracking)