Stockholm, Sweden; May 6th:
Medivir AB (Nasdaq Stockholm: MVIR) today announced that the U.S. Food and Drug Administration (FDA) has granted orphan drug designation (ODD) to MIV-818 for the treatment of patients with hepatocellular carcinoma (HCC), the most common type of primary liver cancer.
FDA grants orphan status to drugs intended to treat rare diseases affecting fewer than 200,000 people in the U.S. The orphan designation provides certain benefits to drug developers, including tax credits for clinical trial expenditures, waived user fees for marketing applications, and eligibility for seven years of marketing exclusivity.
”It is very satisfying that MIV-818 has received a positive opinion on orphan medicinal drug designation by EMA and has been granted orphan drug designation by the FDA for the treatment of HCC”, says Uli Hacksell, CEO at Medivir.