Sunesis Pharmaceuticals' marketing authorisation application for Vosaroxin for AML validated by EMA.
M2 EQUITYBITES-January 5, 2016-Sunesis Pharmaceuticals' marketing authorisation application for Vosaroxin for AML validated by EMA
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Biopharmaceutical company Sunesis Pharmaceuticals (NasdaqCM:SNSS) said on Monday that the European Medicines Agency (EMA) has validated the Marketing Authorisation Application (MAA) for vosaroxin for relapsed refractory acute myeloid leukemia (AML), a rapidly progressing cancer of the blood, in patients aged 60 years and older.
The validation now initiates the Centralized Review process by the EMA's Committee for Medicinal Products for Human Use (CHMP). The CHMP review period is 210 days, after which the CHMP opinion is reviewed by the European Commission, which usually issues a final decision on EU approval within three months.
Additionally, the company's MAA submission will be reviewed in the Centralized Procedure, which if authorised, provides a marketing license valid in all 28 EU member states.
According to the company, QINPREZO (vosaroxin) is an anti-cancer quinolone derivative (AQD), a class of compounds that has not been used previously for the treatment of cancer. Pre-clinical 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 US FDA and European Commission have granted orphan drug designation to vosaroxin for the treatment of AML.
In conjunction, the trademark name QINPREZO is conditionally accepted by the US FDA and the EMA as the proprietary name for the vosaroxin drug product candidate.
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|Publication:||M2 EquityBites (EQB)|
|Date:||Jan 5, 2016|
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