A Framingham-based biotech firm wants the Federal Drug Administration (FDA) to approve its drug to treat preeclampsia in pregnant women.
REVO Biologics Inc. filed an application with the FDA on Tuesday for it to approval a study of its drug ATryn® to treat the pregnancy condition.
The 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.
The FDA approved ATryn® in 2009.
REVO Biologics Inc 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.
“REVO’s focus is to bring life-changing, life-saving medicines to patients, and we believe that ATryn, the first treatment to be developed specifically for the management of preterm preeclampsia, exemplifies this mission,” said Yann Echelard, PhD, President, REVO Biologics. “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.”
The FDA has 30 days to respond to the company's request. The company is seeking 120 women for a trial.
Preeclampsia is a sudden spike in blood pressure that can be life-threatening.
The cause of preeclampsia is unknown, but the number of cases is growing – especially severe cases. In the US, identification and/or incidence of the disorder has increased by approximately 25 percent in the last two decades.
“ATryn has the potential to revolutionize the way we manage preeclampsia in women who are early in their pregnancies by targeting the key underlying mechanisms of preeclampsia,” said Michael J. Paidas, MD, Professor and Co-Director, Yale Women and Children's Center for Blood Disorders, and the lead investigator of PRESERVE-1. “This may slow the progression of the condition, allowing doctors to prolong the gestational age of the baby to improve mortality and morbidity.”
“We have made great strides with expectant management – where mothers with preeclampsia are safely monitored with the goal of prolonging pregnancy and therefore reducing the degree of the baby’s prematurity,” said Baha Sibai, MD, Professor of Obstetrics, Gynecology and Reproductive Sciences at the University of Texas Health Science Center at Houston. “With preterm preeclampsia, every day in utero counts for the baby. The proposed Phase 3 trial with ATryn is an unprecedented step toward providing clinicians an important new therapy to reduce maternal morbidity and prevent maternal complications while safely extending a mother’s pregnancy to allow further development of her baby.”
Preeclampsia and related conditions like HELLP syndrome (hemolysis, elevated liver enzymes and low platelet count) and eclampsia are characterized by a rapid rise in blood pressure for the mother that may lead to seizure, stroke, multiple organ failure or even death for mother or baby. Preeclampsia is the cause of serious illness or death for hundreds of thousands of women and babies every year.
By conservative estimates, preeclampsia is responsible for 76,000 maternal and 500,000 infant deaths each year, worldwide.