FDA approves Raplixa to help control bleeding during surgery


Spray-on fibrin for surgical use. Very cool.

New Drug Approvals

The U.S. Food and Drug Administration today approved Raplixa (fibrin sealant [human]), the first spray-dried fibrin sealant approved by the agency. It is used to help control bleeding during surgery.

April 30, 2015

Release

The U.S. Food and Drug Administration today approved Raplixa (fibrin sealant [human]), the first spray-dried fibrin sealant approved by the agency. It 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…

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Promising New Drug Attacks Cancer Stem Cells in Mesothelioma


The anticancer drug defactnib is currently the subject of clinical trials being conducted in multiple countries. Data from this trial in patients with a type of cancer called mesothelioma have shown that defactnib is potentially quite effective in the treatment of these cancers. Defactnib, which is being marketed by biopharmaceutical company Verastem, Inc.

Mesothelioma attacks the lining of the lung, abdomen and, in some cases, the heart. It has only one known cause; the ingestion or inhalation of asbestos fibers.

This trial is currently in its second phase, and it involves 180 patients in 13 countries. The goal of this trial is to evaluate the ability of Defactnib to kill cancer stem cells that are the main cause of the spread of the tumors and their recurrence. Even though the main focus of this trial has been on treating mesothelioma, positive results have also been achieved by using defactnib to treat other types of cancer as well.

In this trial, mesothelioma patients were treated with a combination of defactnib and pemetrexed for 12 days prior to undergoing surgery. Pemetrexed has been approved by the U.S. Food and Drug Administration to treat mesothelioma. Tumors shrunk in 70 percent of the treated mesothelioma patients. Defactnib is designed to inhibit the activity of a protein called the Focal Adhesion Kinase or FAK. FAK is very important for cancer stem cell function and without it, cancer stem cells cannot grow.

“These and other exciting developments continue to build belief that there may be an end to this horrible disease in sight,” said Russell Budd, president and managing shareholder of the mesothelioma law firm Baron and Budd. “It is extremely encouraging to see signs of progress occur on a regular basis.”