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Medivir granted orphan designation in EU for drug candidate MIV-818.

NORDIC BUSINESS REPORT-June 26, 2020-Medivir granted orphan designation in EU for drug candidate MIV-818


Medivir AB (STO:MVIR), a developer of drugs with a focus on cancer where the unmet medical needs are high, announced on Thursday that the European Commission, in accordance with the opinion from the European Medicines Agency (EMA), has granted orphan medicinal product designation in the EU for MIV-818 for the treatment of patients with hepatocellular carcinoma (HCC), the most common type of primary liver cancer.

Orphan designation provides certain regulatory and financial incentives for companies to develop and market therapies that treat a life-threatening or chronically debilitating condition affecting no more than five in 10,000 persons in the EU.

According to Medivir, this designation can give access to several incentives, including protocol assistance, the EU centralised authorisation procedure and reduced regulatory fees and a potential for a 10-year market exclusivity in the EU.

MIV-818 is a pro-drug designed to selectively treat liver cancer cells and to minimise side effects. It has the potential to become the first liver-targeted, orally administered drug for patients with HCC, Medivir added.

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Publication:Nordic Business Report
Date:Jun 26, 2020
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