|The Medicines Company Announces FDA Approval of RAPLIXA™ (Fibrin Sealant), the First and Only Powdered Fibrin Sealant Ready-to-Use for Mild to Moderate Surgical Bleeding|
According to IMS data, it is estimated that every year, approximately 2.6 – 3 million surgical procedures require the use of a topical hemostat product in the U.S.
RAPLIXA requires no thawing, reconstitution, or mixing and can be applied either directly from the vial or with the RaplixaSpray™ device. The device is a low-pressure spray applicator designed to deliver RAPLIXA to larger bleeding surfaces in difficult to reach areas.
“Controlling mild to moderate bleeding during surgery requires a
hemostatic agent that is easy-to-use and works well across a range of
bleeding settings,” said
“The addition of RAPLIXA to our hemostasis portfolio demonstrates our
commitment to surgery and perioperative care by helping improve the
pathways of care for surgical patients,” said
The approval of RAPLIXA was based on one large Phase 3, multicenter clinical trial involving 721 patients in four countries. This trial demonstrated that RAPLIXA used in conjunction with an absorbable gelatin sponge was superior in achieving hemostasis as compared to treatment with sponge alone when used as an adjunct to hemostasis in patients undergoing vascular, hepatic, spinal, and soft tissue surgery. Adverse events were generally similar between treatment groups and consistent with those observed in patients undergoing surgery.
The Company will discuss this approval in its quarterly earnings call on
Replay is available from
This call is being webcast and can be accessed via The
About RAPLIXA™ (fibrin sealant)
RAPLIXA is a fibrin sealant comprised of human-plasma derived fibrinogen and thrombin that is indicated to provide adjunctive hemostasis for mild to moderate bleeding in adults undergoing surgery when control of bleeding by standard surgical techniques (such as suture, ligature and cautery) is ineffective or impractical.
Important Safety Information
Do not use RAPLIXA intravascularly. Do not use RAPLIXA for the treatment of severe or brisk arterial bleeding. Do not use RAPLIXA in patients known to have anaphylactic or severe systemic reactions to human blood products.
The intravascular application of RAPLIXA may result in thromboembolic events. Air or gas embolism can occur using air- or gas-pressurized sprayers to administer fibrin sealants. The RaplixaSpray device must be operated according to the manufacturer’s instructions. RAPLIXA may carry a risk of transmitting infectious agents, such as viruses, and theoretically, the Creutzfeldt-Jakob disease (CJD) agents, despite manufacturing steps designed to reduce the risk of viral transmission. The use of RAPLIXA may result in allergic type hypersensitivity reactions. If allergic type hypersensitivity symptoms occur, discontinue administration of RAPLIXA immediately.
The most commonly reported adverse reactions (>5%) in patients treated with RAPLIXA were procedural pain, nausea, constipation, pyrexia, and hypotension.
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.
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The Medicines Company