Following last November’s FDA approval, the European Medicines Agency (EMA) has recommended givosiran (Givlaari) for market authorization approval to treat people with acute hepatic porphyria in the European Union. Givosiran was reviewed under EMA’s accelerated assessment programme.
If approved by the European Commission, this will represent yet another important step twoards addressing the needs of individuals affected by painful, recurrent acute hepatic porphyria attacks. Relieving the suffering caused by this debilitating, life-threatening condition is now within reach and the IPPN calls on all stakeholders and decision-makers (drug manufacturer, health technology assessment bodies, heath insurers and, overall, national healthcare systems) to reach the necessary agreements to ensure swift treatment access for patients.
EMA Press Release On Givosiran’s Marketing Authorization Recommendation