The Medicines Company’s Raplixa Gets FDA Nod

The Medicines Company has received US Food and Drug Administration (FDA) approval for Raplixa (fibrin sealant [human]), the first spray-dried fibrin sealant approved by the agency. The drug is used to help control bleeding during surgery.

Raplixa is a biological product approved for use in adults to help control bleeding from small blood vessels when standard surgical techniques, such as suture, ligature or cautery, are ineffective or impractical. When applied to a bleeding site, Raplixa is dissolved in the blood and a reaction starts between the fibrinogen and thrombin proteins. This results in the formation of blood clots to help stop the bleeding.

Raplixa contains fibrinogen and thrombin, two proteins found in human plasma, the liquid portion of blood. The two protein components are individually purified using a manufacturing process that includes virus inactivation and removal steps to help reduce the risk for the transmission of blood-borne viruses. The fibrin sealant components are then spray-dried, blended and packaged in a vial. Raplixa can be applied directly from the original product vial or by spraying with a delivery device onto a bleeding site. It is approved for use in conjunction with an absorbable gelatin sponge.

Raplixa is manufactured by ProFibrix BV, a wholly owned subsidiary of The Medicines Company, based in Parsippany, New Jersey.

The Medicines Company also received FDA approval for Ionsys (fentanyl iontophoretic transdermal system), a needle-free, patient-controlled, pre-programmed fentanyl delivery system, for the short-term management of acute post-operative pain in adult patients requiring opioid analgesia in the hospital.Ionsys offers patients recovering from surgery in the hospital control over their analgesic dosing by pushing a button to dispense fentanyl transdermally via an imperceptible electrical current as needed for pain. IONSYS will only be administered to patients in hospitals enrolled in the Ionsys Risk Evaluation Mitigation Strategy (REMS) program and is not intended for home use. The goal of the Ionsys REMS is to mitigate the risk of respiratory depression resulting from accidental exposure to persons for whom it is not prescribed.

Source:FDA, The Medcines Company (Raplixa) and The Medicines Company (Ionsys)

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