Approvals

Etranacogene dezaparvovec (HEMGENIX), the first gene therapy approved in Europe for the treatment of severe and moderately severe haemophilia B in adult patients, has been approved for national reimbursement by the Spanish Interministerial Pricing Commission for Pharmaceuticals(CIPM).

CSL Behring received conditional marketing authorisation from the European Commission for Hemgenix in February 2023, following on from Us Food and Drug Administration (FDA) approva l the previous month.

Maria Jose Sanchez Losada, general manager, CSL Behring Iberia stated: “We are proud that the Spanish CIPM has recognised HEMGENIX as an innovative one-time treatment option, marking a pivotal moment for Spanish haemophilia B patients and acknowledging the remaining unmet needs in haemophilia B treatment. Following this positive recommendation, our priority will now be to work with healthcare authorities to conclude the agreement and ensure HEMGENIX can reach patients and healthcare professionals throughout the country.”