PARSIPPANY, NJ--(Marketwired - May 9, 2013) - The Medicines Company (NASDAQ : MDCO ) today announced that the U.S. Food and Drug Administration (FDA) has expanded the indication for RECOTHROM®, Thrombin topical (Recombinant) to include use in pediatric patients, following completion of a post-approval pediatric clinical trial commitment. RECOTHROM is a recombinant topical thrombin now indicated to aid hemostasis whenever oozing blood and minor bleeding from capillaries and small venules is accessible and control of bleeding by standard surgical techniques (such as suture, ligature, or cautery) is ineffective or impractical in adult and pediatric populations greater than or equal to one month of age. RECOTHROM provides patients greater than one month of age an alternative to bovine or human plasma derived thrombin.
"Pediatric patients, in various surgical settings, have an increased chance of repeat surgeries. RECOTHROM has been studied in pediatric patients and shown to have a low rate of immunogenicity, and offers an important tool for use in this patient population," said Kevin N. Foster, MD, MBA, FACS, Chief, Burn Services, The Arizona Burn Center at Maricopa Medical Center.
The recent FDA approval is based, in part, on data from a completed Phase 4, open-label, single-group safety and immunogenicity study. This study was conducted in 30 pediatric patients greater than one month of age undergoing synchronous burn wound excision and skin grafting. The safety of RECOTHROM in pediatric patients greater than or equal to one month of age is supported by these data and by extrapolation of efficacy from adequate and well-controlled studies of RECOTHROM in adults. Safety and efficacy has not been established in neonates.
"Our purpose is to save lives, alleviate suffering and improve the economic efficiency of the approximately 2,500 leading hospitals in the world," said Brent Furse, Senior Vice President and Chief Customer Officer of The Medicines Company. "There are several hundred leading hospitals in the United States that conduct thousands of surgical procedures in pediatric patients each year. We believe the expanded pediatric indication for RECOTHROM provides an opportunity to make this topical hemostat available to a broader range of surgical patients."
About The Medicines CompanyThe Medicines Company (NASDAQ : MDCO ) provides medical solutions to improve health outcomes for patients in acute and intensive care hospitals worldwide. These solutions comprise medicines and knowledge that directly impact the survival and well-being of critically ill patients. The Medicines Company's website is www.themedicinescompany.com.
