The European Commission (EC) has granted orphan drug designation to Sunesis Pharmaceuticals' Vosaroxin drug.
Vosaroxin is a first-in-class anti-cancer quinolone derivative, (AQD), used for the treatment of acute myeloid leukemia (AML).
Sunesis executive vice president and Development chief marketing officer Adam Craig said the EC's decision reinforces the potential of Vosaroxin and recognizes the need for new treatment options in AML.
"European orphan drug designation is the latest in a series of regulatory milestones that have strengthened the commercial opportunity for vosaroxin on both sides of the Atlantic," Craig added.
"These include the potential for market exclusivity to 2030 and an expedited review process in the U.S., as well as new patents issued in the European Union with exclusivity to 2025."
Currently, the company is enrolling patients in its Phase 3 multinational randomized double-blind placebo-controlled pivotal VALOR study of Vosaroxin in combination with cytarabine.
The trial is expected to enroll 450 evaluable patients who will be randomized to receive either Vosaroxin on days one and four in combination with cytarabine daily for five days, or placebo in combination with cytarabine.
