Results published simultaneously in the Journal of the American College of Surgeons
PARSIPPANY, NJ, USA I October 28, 2014 I The Medicines Company (MDCO) today announced the presentation of the results of the pivotal Phase III clinical trial of the investigational hemostatic agent RAPLIXA™ (fibrin sealant), formerly known as Fibrocaps, at the 100th Clinical Congress of the American College of Surgeons in San Francisco, CA. As previously reported, the Phase III trial, FINISH-3, which studied a total of 719 patients, met all primary and secondary hemostasis efficacy endpoints in four distinct surgical indications of spinal surgery, hepatic resection, vascular surgery and soft tissue dissection. RAPLIXA, currently under regulatory review with the U.S. Food and Drug Administration and the European Medicines Agency, is a dry powder topical formulation of fibrinogen and thrombin being developed to aid in hemostasis during surgery.
FINISH-3 is an international, randomized, single-blind, controlled trial that compared the efficacy and safety of RAPLIXA™, a ready-to-use, dry-powder fibrin sealant containing human plasma-derived thrombin and fibrinogen with gelatin sponge, vs. gelatin sponge alone for use as a hemostat for surgical bleeding in four indications (spinal, hepatic, vascular, soft tissue dissection). Adults with mild/moderate surgical bleeding – randomized 2:1; RAPLIXA™ vs. gelatin sponge – were treated at a single bleeding site (Day 1). Time to hemostasis (TTH) over five minutes was compared (log-rank statistic) within each indication. Safety follow-up continued to Day 29.
“In the FINISH-3 Trial, RAPLIXA™ was well tolerated and significantly reduced TTH relative to gelatin sponge alone in all four surgical indications. These findings demonstrate the broad utility of RAPLIXA™ as a hemostatic agent for mild to moderate surgical bleeding,” said Grant V. Bochicchio, MD, MPH, FACS, Washington University School of Medicine, St Louis, MO, and lead author.
Patients were treated (RAPLIXA™: 480; gelatin sponge: 239) while undergoing spinal (n=183), vascular (n=175), hepatic (n=180), or soft tissue (n=181) procedures. RAPLIXA™ was applied by spray device in 53 percent of all procedures (94 percent of hepatic and soft tissue procedures). RAPLIXA™ significantly reduced TTH compared to gelatin sponge; estimated hazard ratios were 3.3, 2.1, 2.3, and 3.4 for the four surgical indications, respectively (each p<0.001; primary endpoint). RAPLIXA™ significantly reduced median TTH for each indication (p<0.0001), and was superior for secondary efficacy endpoints of restricted mean TTH (p<0.0001) and probability of hemostasis at 3 (p<0.0001) and 5 (p≤0.002) minutes. Adverse event incidences were generally similar between treatment arms. Non-neutralizing, anti-thrombin antibodies developed in 2 percent of RAPLIXA™-treated and 3 percent of gelatin sponge-treated patients.
“The results of the FINISH-3 trial demonstrate that RAPLIXA™ has the potential to become an important hemostatic product – complementary to Recothrom® Thrombin, topical (Recombinant) – and a valuable addition to our growing surgical care portfolio. RAPLIXA is under review for a Biological License Application (BLA) in the USA. In April of this year, we announced the PDUFA date for the RAPLIXA filing is January 31, 2015. RAPLIXA’s filing in Europe has been validated and under review through the centralized process at the EMA,” said Adam Sharkawy, PhD, Senior Vice President, and Surgery and Perioperative Care Global Innovation Group Leader at The Medicines Company.e
About RAPLIXA™ (fibrin sealant)
RAPLIXA™ is an investigational hemostatic agent, not approved for commercial use in any market. RAPLIXA is a mixture of two essential blood clotting proteins, fibrinogen and thrombin, formulated as a unique dry powder topical product, which is being developed to aid in hemostasis during surgery.
About The Medicines Company
The Medicines Company’s purpose is to save lives, alleviate suffering and contribute to the economics of healthcare by focusing on 3000 leading acute/intensive care hospitals worldwide. Its vision is to be a leading provider of solutions in three areas: serious infectious disease care, acute cardiovascular care and surgery and perioperative care. The company operates in the Americas, Europe and the Middle East, and Asia Pacific regions with global centers today in Parsippany, NJ, USA and Zurich, Switzerland.
SOURCE: The Medicines Company
Post Views: 171
Results published simultaneously in the Journal of the American College of Surgeons
PARSIPPANY, NJ, USA I October 28, 2014 I The Medicines Company (MDCO) today announced the presentation of the results of the pivotal Phase III clinical trial of the investigational hemostatic agent RAPLIXA™ (fibrin sealant), formerly known as Fibrocaps, at the 100th Clinical Congress of the American College of Surgeons in San Francisco, CA. As previously reported, the Phase III trial, FINISH-3, which studied a total of 719 patients, met all primary and secondary hemostasis efficacy endpoints in four distinct surgical indications of spinal surgery, hepatic resection, vascular surgery and soft tissue dissection. RAPLIXA, currently under regulatory review with the U.S. Food and Drug Administration and the European Medicines Agency, is a dry powder topical formulation of fibrinogen and thrombin being developed to aid in hemostasis during surgery.
FINISH-3 is an international, randomized, single-blind, controlled trial that compared the efficacy and safety of RAPLIXA™, a ready-to-use, dry-powder fibrin sealant containing human plasma-derived thrombin and fibrinogen with gelatin sponge, vs. gelatin sponge alone for use as a hemostat for surgical bleeding in four indications (spinal, hepatic, vascular, soft tissue dissection). Adults with mild/moderate surgical bleeding – randomized 2:1; RAPLIXA™ vs. gelatin sponge – were treated at a single bleeding site (Day 1). Time to hemostasis (TTH) over five minutes was compared (log-rank statistic) within each indication. Safety follow-up continued to Day 29.
“In the FINISH-3 Trial, RAPLIXA™ was well tolerated and significantly reduced TTH relative to gelatin sponge alone in all four surgical indications. These findings demonstrate the broad utility of RAPLIXA™ as a hemostatic agent for mild to moderate surgical bleeding,” said Grant V. Bochicchio, MD, MPH, FACS, Washington University School of Medicine, St Louis, MO, and lead author.
Patients were treated (RAPLIXA™: 480; gelatin sponge: 239) while undergoing spinal (n=183), vascular (n=175), hepatic (n=180), or soft tissue (n=181) procedures. RAPLIXA™ was applied by spray device in 53 percent of all procedures (94 percent of hepatic and soft tissue procedures). RAPLIXA™ significantly reduced TTH compared to gelatin sponge; estimated hazard ratios were 3.3, 2.1, 2.3, and 3.4 for the four surgical indications, respectively (each p<0.001; primary endpoint). RAPLIXA™ significantly reduced median TTH for each indication (p<0.0001), and was superior for secondary efficacy endpoints of restricted mean TTH (p<0.0001) and probability of hemostasis at 3 (p<0.0001) and 5 (p≤0.002) minutes. Adverse event incidences were generally similar between treatment arms. Non-neutralizing, anti-thrombin antibodies developed in 2 percent of RAPLIXA™-treated and 3 percent of gelatin sponge-treated patients.
“The results of the FINISH-3 trial demonstrate that RAPLIXA™ has the potential to become an important hemostatic product – complementary to Recothrom® Thrombin, topical (Recombinant) – and a valuable addition to our growing surgical care portfolio. RAPLIXA is under review for a Biological License Application (BLA) in the USA. In April of this year, we announced the PDUFA date for the RAPLIXA filing is January 31, 2015. RAPLIXA’s filing in Europe has been validated and under review through the centralized process at the EMA,” said Adam Sharkawy, PhD, Senior Vice President, and Surgery and Perioperative Care Global Innovation Group Leader at The Medicines Company.e
About RAPLIXA™ (fibrin sealant)
RAPLIXA™ is an investigational hemostatic agent, not approved for commercial use in any market. RAPLIXA is a mixture of two essential blood clotting proteins, fibrinogen and thrombin, formulated as a unique dry powder topical product, which is being developed to aid in hemostasis during surgery.
About The Medicines Company
The Medicines Company’s purpose is to save lives, alleviate suffering and contribute to the economics of healthcare by focusing on 3000 leading acute/intensive care hospitals worldwide. Its vision is to be a leading provider of solutions in three areas: serious infectious disease care, acute cardiovascular care and surgery and perioperative care. The company operates in the Americas, Europe and the Middle East, and Asia Pacific regions with global centers today in Parsippany, NJ, USA and Zurich, Switzerland.
SOURCE: The Medicines Company
Post Views: 171
