Pfizer's Fragmin Receives FDA Approval as First Anticoagulant for Pediatric Patients with Recurrent Venous Thromboembolism

VCBeat (WeChat ID: vcbeat) has learned that Fragmin, an anticoagulant under global biopharmaceutical giant Pfizer, has recently received FDA approval. This marks the first drug approved for the treatment of pediatric patients with recurrent venous thromboembolism (VTE).

Fragmin is a subcutaneous injection of dalteparin sodium that effectively prevents blood clot formation in cancer patients and can be used in pediatric patients older than one month. As early as 1994, the drug was approved by the FDA to reduce the risk of deep vein thrombosis in patients undergoing hip replacement surgery or abdominal surgery. The drug can also be used concurrently with aspirin to prevent ischemic cardiac complications and non-Q-wave myocardial infarction in patients with unstable angina.

It is reported that Fragmin was developed by Pfizer. As a global biopharmaceutical giant founded in 1849 and headquartered in New York, USA, Pfizer boasts world-leading research and development and manufacturing capabilities. Its product portfolio spans chemical drugs, biologics, vaccines, and consumer health products.

Dr. Richard Pazdur, Director of the FDA’s Oncology Center of Excellence and Acting Director of the Office of Hematology and Oncology Products in the FDA’s Center for Drug Evaluation and Research, stated: “Most pediatric patients with VTE suffer from serious underlying conditions, such as cancer or congenital heart disease. Previously, there were no treatments available for pediatric patients with VTE; therefore, we granted priority review to Fragmin. Moving forward, we will continue to provide innovative therapeutic options for pediatric patients with unmet medical needs.”

Venous thromboembolism (VTE) is a major complication in cancer patients, with an incidence rate of 4% to 20%. Cancer patients undergoing chemotherapy are at high risk for blood clot formation due to intravenous drug administration, which can lead to patient death. This condition includes deep vein thrombosis and pulmonary embolism.

In a clinical trial, Pfizer conducted a single study involving 38 pediatric patients with deep vein thrombosis and pulmonary embolism. These patients received three months of treatment with Fragmin, with higher single doses administered to patients of greater age and weight. At the end of the trial, 21 patients were stable, 7 showed symptom improvement, 2 remained unchanged, and 1 experienced a recurrence.

It is understood that the most common side effect of Fragmin is bleeding, including significant blood loss from vessels, thrombocytopenia, hematoma, pain at the injection site, and transient elevation of transaminase levels. The FDA has stated that healthcare professionals should closely monitor patients using Fragmin for signs of bleeding.

(Compiled by Jiao Yanli)