Sunesis Pharmaceuticals, Inc. (NASDAQ:SNSS) announced that the European Medicines Agency (EMA) has validated the Marketing Authorization Application (MAA) for vosaroxin 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 EU 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, Ph.D., Vice President, Regulatory Affairs and Medical Writing. “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.”
“We believe European marketing authorization would represent a significant opportunity both commercially and in providing regulatory validation for other geographies around the world,” said Daniel Swisher, Chief Executive Officer of Sunesis. “We look forward to providing more updates in 2016 as we move forward with this regulatory process.” (Original Source)
Shares of Sunesis Pharmaceuticals closed last Thursday at $0.8975, down $0.03 or -3.18%. SNSS has a 1-year high of $3.72 and a 1-year low of $0.74. The stock’s 50-day moving average is $0.89 and its 200-day moving average is $1.41.
Sunesis Pharmaceuticals Inc is a biopharmaceutical company engaged in the development and commercialization of new oncology therapeutics for the treatment of solid and hematologic cancers.