The venous thromboembolism therapeutics pipeline is expected to witness considerable growth in the coming year due to the development of novel oral anticoagulants as a reasonable and established treatment option. The regulatory bodies are supporting the drug development process through different types of designations and funding. The pipeline is being driven by different factors such as increasing awareness regarding the venous thromboembolism therapeutics pipeline, high demand for safe, effective and affordable medications, technological advancements and increasing prevalence of the venous thromboembolism.
According to American Heart Association, Venous thromboembolism (VTE) collectively develops as a combination of deep vein thrombosis (DVT) and pulmonary embolism (PE), two life-threatening conditions. Venous thromboembolism is a common and preventable disease in which the clot formation occurs in the vein associated with Venous thromboembolism. In deep vein thrombosis, a clot formed in a deep vein, usually in the leg. Pulmonary embolism is a deep vein thrombosis clot that breaks free from a vein wall, travels to the lungs and blocks some or all of the blood supply. Blood clots in the thigh are more likely to break off and travel to the lungs than the clots in lower leg or other parts of the body.
Bayer is developing a drug by the name, Rivaroxaban for the treatment of venous thromboembolism which is currently in Phase III clinical development. Rivaroxaban is a non-vitamin K antagonist. In March 2017, Janssen Pharmaceuticals, Inc. presented a new Phase III results from EINSTEIN CHOICE, a part of the clinical research program for XARELTO (rivaroxaban) in patient with venous thromboembolism. It was found that patient who have received XARELTO (rivaroxaban), either 10 mg or 20 mg once daily over an extended time period, had significantly fewer recurrent blood clots and similar rates of major bleeding compared to those taking aspirin 100 mg once daily. XARELTO 10 mg reduced the risk of recurrent venous thromboembolism by 74% and XARELTO 20 mg by 66%. Therefore, promising results of the Phase III drug candidates, involvement of key players, increasing awareness regarding the treatment has been driving the pipeline growth. However, complex mechanism of action of the disease, high cost of treatment and the side effects associated with the treatment act as key barriers for growth of the pipeline.
According to Centers for Disease Control and Prevention, the precise number of people affected by DVT/PE is unknown, although as many as 900,000 people could be affected (1 to 2 per 1,000) each year in the U.S. It is estimated that every year approximately, 60,000-100,000 Americans die of DVT/PE (also called venous thromboembolism). Around 10% to 30% of people die within one month of diagnosis. Approximately 5% to 8% of the U.S. population has one of several genetic risk factors, also known as inherited thrombophilia in which a genetic defect can be identified that increases the risk for thrombosis.
Some of the companies having a pipeline of venous thromboembolism therapeutics include Bristol-Myers Squibb Company, Pfizer, Inc., Sanofi-Aventis, Daiichi Sankyo Co. Ltd., Astellas Pharma Inc. and Johnson & Johnson.