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news.rEVO Biologics, a subsidiary of LFB, has 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.
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The objective of the Phase III 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.
rEVO is seeking to expand the approved labeling for ATryn to include preeclampsia. ATryn is currently indicated for the prevention of peri-operative and peripartum thromboembolic events in hereditary antithrombin deficient patients. It is not indicated for the treatment of thromboembolic events.
If proven to be safe and effective, ATryn may be the first drug specifically indicated for the management of preterm preeclampsia in pregnant women.
rEVO Biologics president Dr Yann Echelard noted the company’s focus is to bring life-changing, life-saving medicines to patients, and it believes that ATryn, the first treatment to be developed specifically for the management of preterm preeclampsia, exemplifies this mission.
"We are committed to finding solutions for women with preeclampsia, and to working with the OB/GYN community, maternal fetal medicine specialists and patient advocacy groups to bring this important therapy to patients," Dr Echelard added.