Company Announces FDA Acceptance of Investigational New Drug Application to Initiate PRESERVE-1— enrollment to begin mid-2014
rEVO Biologics Inc., a subsidiary of LFB SA, today announced the initiation of the Phase 3 clinical program for ATryn® [antithrombin (Recombinant)] for the treatment of preeclampsia in pregnant women during the 24th to 28th week of pregnancy. Preeclampsia at this stage of pregnancy is rare and extremely serious, occurring in a subset of all preeclampsia patients. The objective of the PRESERVE-1 trial is to assess whether ATryn prolongs pregnancy in mothers with early-onset preeclampsia and consequently improves the health of their babies.
Preeclampsia is an area of high unmet medical need, particularly when it occurs early in pregnancy. Previously, rEVO announced the submission of an Investigational New Drug (IND) Application with the U.S. Food and Drug Administration (FDA) for ATryn for the treatment of early-onset preeclampsia in pregnant women. The FDA has now indicated that the PRESERVE-1 trial may proceed.
“We are pleased to initiate the PRESERVE-1 clinical trial for the management of early-onset preeclampsia. This is an important step forward in our pursuit to bring a novel treatment for early-onset preeclampsia where nothing exists today,” said Yann Echelard, PhD, President, rEVO Biologics. “There is an incredible need for treatments to manage preeclampsia, particularly when it occurs early in pregnancy. If proven to be safe and effective, ATryn will be the first drug specifically indicated for the management of preeclampsia in pregnant women during the 24th to 28th week of pregnancy to prolong gestation and decrease fetal and neonatal morbidity and mortality.”
Preeclampsia is a life-threatening condition that occurs in approximately six to eight percent of all pregnancies and typically occurs after the twentieth week of pregnancy. The cause of preeclampsia is unknown, but the number of cases is growing. In the U.S., the incidence of the disorder has increased by approximately 25 percent since 1987. Preeclampsia is particularly devastating when it occurs very early during the pregnancy, as it leads to the birth of severely premature babies. At present, delivery of the baby is the only known treatment for preeclampsia.
About the PRESERVE-1 Clinical Trial
PRESERVE-1(Pharmacokinetics, Safety and Efficacy Study of Recombinant Antithrombin Versus Placebo in Preterm Preeclampsia) is a Phase 3, randomized, double-blind, placebo controlled trial of 120 patients assessing the safety, efficacy and pharmacokinetics (PK) of ATryn in patients who are being expectantly managed for early-onset preeclampsia.
Efficacy will be assessed by comparing the difference in gestational age from the time of randomization into the trial until delivery of the baby in women given ATryn to those given placebo. The effect of ATryn on neonatal clinical outcomes will also be assessed.
Preeclampsia is a condition that only occurs in pregnancy and affects the placenta. Abnormal development of blood vessels from the uterus to the placenta may lead to decreased blood flow, nutrients and oxygen from mother to baby, placing the baby at risk for prematurity and abnormal fetal growth. The lining of the blood vessels (endothelium) also becomes damaged causing inflammation that extends from the placenta throughout the mother’s blood vessels and internal organs. As a result, high blood pressure, stroke, seizures and liver and kidney problems can occur or even death for mother or 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.
Indications and Usage
ATryn is a recombinant antithrombin indicated for the prevention of peri-operative and peri-partum thromboembolic events in hereditary antithrombin deficient patients.
It is not indicated for treatment of thromboembolic events in hereditary antithrombin deficient patients.
Important Safety Information
ATryn is contraindicated in patients with known hypersensitivity to goat and goat milk proteins. Allergic-type hypersensitivity reactions, including anaphylaxis, are possible. Patients must be closely monitored and carefully observed for any symptoms throughout the infusion period. Patients should be informed of the early signs of hypersensitivity reactions including hives, generalized urticaria, tightness of the chest, wheezing, hypotension and anaphylaxis. If these symptoms occur during administration, treatment must be discontinued immediately and emergency treatment should be administered.
The anticoagulant effect of drugs that use antithrombin to exert their anticoagulation may be altered when ATryn is added or withdrawn. To avoid excessive or insufficient anticoagulation, coagulation tests suitable for the anticoagulant used (e.g., aPTT and anti-Factor Xa activity) are to be performed regularly, at close intervals and in particular in the first hours following the start or withdrawal of ATryn. Additionally, patients should be monitored for the occurrence of bleeding or thrombosis in such situations.
The serious adverse reaction that has been reported in clinical studies is hemorrhage (intra-abdominal, hemarthrosis and post procedural). The most common adverse events reported in clinical trials at a frequency of ≥5% are hemorrhage and infusion site reaction.
For more information, please view full Prescribing Information for ATryn, visit www.atryn.com or call 1-800-610-3776.
To report suspected adverse reactions contact rEVO Biologics Inc.at 1-800-610-3776 or the FDA at 1-800-FDA-1088 or www.fda.gov/MedWatch.
About rEVO Biologics
rEVO Biologics Inc. (www.revobiologics.com) is a commercial-stage biopharmaceutical company focused on the development and commercialization of specialty therapeutics to address unmet medical needs in patients with rare, life-threatening conditions. The company’s lead product, ATryn, is the first and only plasma-free antithrombin concentrate. ATryn received FDA approval in 2009. The company has a number of products in its pipeline and in clinical trials in the areas of hematology, oncology, genetic disorders and autoimmune disease, and is actively seeking additional indications for its lead product.
About LFB group
LFB is a biopharmaceutical group that develops, manufactures and markets medicinal products for the treatment of serious and often rare diseases in several major therapeutic fields, including hemostasis, immunology and intensive care. The LFB Group is the leading manufacturer of plasma-derived medicinal products in France and sixth worldwide and is also among the leading European companies for the development of new-generation medicinal products or treatments based on biotechnologies. The LFB Group is pursuing a growth strategy that seeks to extend its activities at the international level and develop innovative therapies. To that end, the LFB Group currently markets its products in 20 countries around the world with a global turnover of €466 million in 2012.
Feinstein Kean Healthcare