European regulators have issued a positive recommendation for Zeltia's Yondelis, an oncology drug used in combination with Johnson & Johnson's Doxil to treat ovarian cancer. It's a major boost for the Spanish company, which suffered a setback when the FDA rejected the drug earlier this month. An FDA advisory committee expressed concerns that the drug was linked to serious side effects. Zeltia will have to provide additional information, including overall survival data and additional clinical pharmacology studies if it hopes to gain approval in the US.
A spokesperson for the company said other countries could follow the EMEA's move and approve Yondelis. "It's highly probable that other countries will now approve Yondelis and that within a few months the only country which hasn't approved it will be the United States," Luis Mora, managing director for Zeltia's PharmaMar biotech unit, said in Reuters. The drug could net Zeltia up to $440.5 million a year. Yondelis is already approved in Europe to treat soft tissue sarcoma.
- here's the article from Reuters