Alnylam receives approval for Onpattro in Europe

The European Medicines Agency (EMA) has granted a marketing authorisation to patisiran (Onpattro) – the first RNA interference drug approved within the EU. Onpattro is indicated for the treatment of hereditary transthyretin-mediated amyloidosis (hATTR amyloidosis) in adults with stage 1 or stage 2 polyneuropathy.

This comes after its approval by the Food and Drug Administration (FDA) in the US earlier last month. However, a report by the Institute for Clinical and Economic Review (ICER) concluded that the drugs list price would need to fall between 90-95 % from its current list price of $450,000 to between $24,700 and $46,488 to meet cost-effectiveness thresholds of $100,000 and $150,000 per QALY respectively.

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Published 3. September 2018 in News EU