Sunesis Pharma (SNSS) Submits Responses to EMA Day 120 List of Questions for Vosaroxin MAA
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Sunesis Pharmaceuticals, Inc. (Nasdaq: SNSS) announced that it has submitted its responses to European Medicines Agency (EMA) Day 120 List of Questions issued by the Committee for Medicinal Products for Human Use (CHMP) as part of the centralized review process of the Marketing Authorization Application (MAA) for vosaroxin as a treatment for relapsed/refractory acute myeloid leukemia (AML) in patients aged 60 years and older. Sunesis expects to receive the EMA Day 180 List of Outstanding Issues before year-end.
“We are pleased with the comprehensive set of answers and additional analyses that our team has provided in response to the EMA’s Day 120 list of questions,” said Daniel Swisher, President and Chief Executive Officer of Sunesis. “As our regulatory efforts progress to bring vosaroxin to market in Europe as a treatment for relapsed/refractory AML, we are advancing active dialogues with potential pharma collaborators toward the goal of supporting a market launch in 2017. With the clock now restarting, we anticipate being one step closer to that goal.”
About QINPREZO™ (vosaroxin)QINPREZO™ (vosaroxin) is an anti-cancer quinolone derivative (AQD), a class of compounds that has not been used previously for the treatment of cancer. Preclinical data demonstrate that vosaroxin both intercalates DNA and inhibits topoisomerase II, resulting in replication-dependent, site-selective DNA damage, G2 arrest and apoptosis. Both the U.S. Food and Drug Administration (FDA) and European Commission have granted orphan drug designation to vosaroxin for the treatment of AML. Vosaroxin is an investigational drug that has not been approved for use in any jurisdiction.
Vosaroxin’s Marketing Authorization Application for relapsed refractory AML is currently under review by the European Medicines Agency, and a regulatory decision regarding approval is expected in 2017.
The trademark name QINPREZO is conditionally accepted by the FDA and the EMA as the proprietary name for the vosaroxin drug product candidate.
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