Aveo Pharmaceuticals Inc. has won orphan medicinal product designation from the European Medicines Agency (EMA) for its renal cell carcinoma treatment, tivozanib, a triple VEGF receptor inhibitor.
A press release from the company today noted that the EMA cited high rates of renal cell carcinoma, a type of kidney cancer, in people in the European Union as a major factor in approving the drug for orphan status.
Aveo returned positive results from its Phase 2 clinical trial and enrolled patients in its Phase 3 clinical trial in February. The trial, called TIVO-1, compares tivozanib to sorafenib, an EMA-approved and FDA-approved drug to treat renal cell carcinoma, to measure progression-free survival.
Cambridge-based Aveo announced in March that it had priced its initial public offering to bring in up to $81 million – falling short of its February registration statement update, calling for an expected $91 million to $105 million.
Aveo is a late-stage biopharmaceutical company that has collaborated with Eli Lilly, Merck, OSI Pharmaceuticals and Schering-Plough. The company was founded in 2002 as GenPath Pharmaceuticals Inc. and has since raised more than $100 million in venture funding.