EMA validates Sunesis' application for vosaroxin in AML

USA-based Sunesis Pharmaceuticals (Nasdaq: SNSS) saw its shares rise 3.3% to $0.93 after it announced that the European Medicines Agency has validated the Marketing Authorization Application for vosaroxin, proposed trade name Qinprezo, as a treatment for relapsed refractory acute myeloid leukemia (AML) in patients aged 60 years and older.

Validation confirms that the submission is complete and initiates the Centralized Review process by the EMA’s Committee for Medicinal Products for Human Use (CHMP). Under Centralized Review, the CHMP review period is 210 days, excluding question or opinion response periods, after which the CHMP opinion is reviewed by the European Commission, which usually issues a final decision on European Union approval within three months. The MAA submission will be reviewed in the Centralized Procedure, which if authorized, provides a marketing license valid in all 28 EU member states.

“Validation of our vosaroxin MAA begins the EMA review process and brings us another step closer to delivering a new treatment option to patients with relapsed refractory AML,” said Deborah Thomas, vice president, regulatory affairs and medical writing, adding: “Following encouraging interactions with the agency last summer, we look forward to progressing to the next stage of the review process, which includes the 120-day questions following the assessment report by the CHMP.”