Medivir gets orphan medicinal product designation for MIV-818 for HCC in EU

Swedish biotech company Medivir has secured orphan medicinal product designation from the European Commission for MIV-818 for the treatment of hepatocellular carcinoma (HCC).

The orphan medicinal product designation to the pro-drug in the European Union (EU) was granted in accordance with the opinion from the European Medicines Agency (EMA).

Although hepatocellular carcinoma is considered to be the fifth most common cancer worldwide, it is a rare disease in Europe and also in the US.

According to Medivir, although therapies are available for this type of primary liver cancer, treatment benefits for intermediate and advanced forms of the disease are low and death rates remain high.

Through the orphan medicinal product designation, Medivir stands to receive certain regulatory and financial incentives. The designation can also give the Swedish biotech company access to various incentives such as protocol assistance, the EU centralized authorization procedure, and reduced regulatory fees. The orphan medicinal product designation also gives the potential for a 10-year market exclusivity in the European Union for MIV-818.