rEVO Biologics Announces The Submission Of An IND For Atryn® In Preeclampsia
Published: Feb 25, 2014
FRAMINGHAM, Mass.--(BUSINESS WIRE)--rEVO Biologics Inc., a subsidiary of LFB SA, today announced the submission of an Investigational New Drug (IND) Application with the US Food and Drug Administration (FDA) for ATryn® [antithrombin (Recombinant)] for the treatment of preeclampsia in pregnant women. The objective of the Phase 3 study (PRESERVE-1) is to assess whether ATryn® may safely prolong pregnancy in mothers with very early preterm preeclampsia and consequently decrease prematurity-associated morbidity and mortality of their babies. This study will focus on pregnant women who are at gestational age 24 to 28 weeks – an area of significant unmet need. Babies born at these gestational ages have a high risk of mortality or severe morbidity. During this period, prolongation of pregnancy, even by a few days, can lead to a significant improvement in the well-being of the newborns.
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