MYR Pharmaceuticals gains conditional EC approval for Hepcludex

4 August 2020

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Following a positive European Medicines Agency recommendation in May, the European Commission (EC) has now granted the conditional marketing authorization (CMA) for Hepcludex (bulevirtide), the lead product of German biotech MYR Pharmaceuticals.

Hepcludex has been approved as the first treatment option for adult patients with chronic hepatitis delta virus infection and compensated liver disease in Europe.

Conditional approval is granted to a medicinal product that fulfils an unmet medical need where the benefit of immediate availability outweighs the risk of less comprehensive data than normally required. It requires additional monitoring and post-marketing data before full approval is granted.

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