Sunesis Pharmaceuticals Announces European Medicines Agency Acceptance of Pediatric Investigation Plan for Qinprezo For AML
Sunesis Pharmaceuticals, Inc. (Nasdaq: SNSS) today announced that the Pediatric Committee of the European Medicines Agency (EMA) has issued a positive opinion on the Company's Pediatric Investigation Plan (PIP) for Qinprezo™ (vosaroxin), Sunesis' lead drug candidate. Sunesis is currently conducting the VALOR trial, a pivotal Phase 3, randomized, double-blind, placebo-controlled clinical trial in patients with first relapsed or refractory acute myeloid leukemia (AML).
A PIP is part of the EMA approval process and must be accepted prior to submission of a Marketing Authorization Application (MAA) for the drug in the European Union. A PIP describes how a company intends to evaluate the use of a given drug in children. Completion of studies outlined in the PIP prior to European Union approval is not a requirement for MAA submission if deferral for completion has been received.
"We are pleased with the acceptance of our PIP by the EMA, an important step leading into a potential filing of our Marketing Authorization Application for Qinprezo in Europe," said Daniel Swisher, Chief Executive Officer of Sunesis. "AML remains a significant unmet medical need, one which has seen little innovation in the last 40 years. We look forward to understanding Qinprezo's potential within first relapsed or refractory AML with the unblinding of VALOR expected in the third or fourth quarter of 2014."
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