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FDA plans to not to hold advisory committee meeting for Portola’s betrixaban NDA

Published 09 February 2017

The US Food and Drug Administration (FDA)’s Center for Drug Evaluation and Research (CDER) is not planning to hold an Advisory Committee meeting for Portola Pharmaceuticals' New Drug Application (NDA) for betrixaban.

Betrixaban is an oral, once-daily Factor Xa inhibitor anticoagulant.

The NDA for betrixaban, an FDA Fast Track-designated therapy, is under priority review by the FDA for extended-duration prophylaxis of venous thromboembolism (VTE) in acute medically ill patients with risk factors for VTE.

Portola research and development executive vice president John T. Curnutte, M.D., Ph.D. said: “Based on the APEX data, we remain confident in the potential for betrixaban to be approved as the first anticoagulant for extended-duration VTE prophylaxis in high-risk acute medically ill patients.

“We look forward to continuing our ongoing discussions with the FDA as part of the priority review process.”

About VTE in Acute Medically Ill Patients 

Acute medically ill patients are those hospitalized for serious, common medical conditions, including heart failure, stroke, infection and pulmonary disease. Because of their underlying disorder or immobilization during hospitalization, they are at increased risk of VTE, a serious and potentially life-threatening blood clot (thrombus). VTE, which includes both deep vein thrombosis (DVT) and pulmonary embolism (PE), is a major cause of preventable morbidity and mortality and re-hospitalization in the acute medically ill patient population.

In the G7 countries, an estimated 24 million acute medically ill patients are hospitalized each year and are at risk of VTE, either while in the hospital or following discharge.

More than 1 million VTE events and 150,000 VTE-related deaths occur annually in acute medically ill patients in the G7 countries, despite the standard use of injectable enoxaparin and other heparins in the hospital. More than half of VTE events occur after the patient is discharged. However, no anticoagulant, including enoxaparin or any of the marketed oral Factor Xa inhibitors, is approved for in-hospital and extended-duration VTE prophylaxis in acute medically ill patients who are hospitalized.

About Betrixaban 

Betrixaban, an investigational drug, directly inhibits the activity of Factor Xa, an important validated target in the blood coagulation pathway, to prevent life-threatening thrombosis. Betrixaban has distinct properties that may allow it to demonstrate clinical benefit without the significant imbalance in the risk of major bleeding seen with other agents in the class. These include a 19-25-hour half-life for once-daily dosing; a low peak-to-trough drug concentration ratio that reduces anticoagulant variability; low renal clearance; and no significant CYP3A4 metabolism, which may reduce the risk of drug-drug interactions.

In the EU, the European Medicines Agency’s Committee for Medicinal Products for Human Use (CHMP) is reviewing the Marketing Authorization Application for betrixaban under a standard 210-day review period.

Source: Company Press Release