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The European Medicines Agency’s Committee for Medicinal Products for Human Use (CHMP) has issued a negative opinion recommending refusal of marketing authorization for the factor Xa inhibitor betrixaban (Dexxience).
Portola Pharmaceuticals, Inc. is seeking approval of betrixaban for the prevention of venous thromboembolism (VTE) in adults hospitalized for an acute medical illness with risk factors for VTE, including VTE-related death.
The marketing authorization application for betrixaban was supported by data from the phase 3 APEX study. In this study, researchers compared oral betrixaban to injectable enoxaparin for the prevention of VTE in patients with acute medical illnesses.
The CHMP said APEX did not satisfactorily show that betrixaban’s benefits outweigh its risk in this patient population. The study results were not considered reliable because some test results for VTEs were not available.
In addition, patients treated with betrixaban had more episodes of bleeding than those treated with enoxaparin. This was considered an important concern given that betrixaban was expected to be used in patients with serious underlying conditions.
For these reasons, the CHMP recommended that betrixaban be refused marketing authorization.
Portola Pharmaceuticals said it intends to appeal the CHMP’s opinion and ask the committee for a re-examination.
“We believe we have generated substantial evidence which demonstrates the clinically meaningful benefit of betrixaban in reducing VTE and VTE-related deaths in this vulnerable patient population, and we remain confident in its potential to have a major public health impact,” said Jack Lawrence, MD, chief medical officer of Portola Pharmaceuticals.
“The re-examination process allows us the opportunity to address the CHMP’s questions and provide further clarification as needed, with the goal of making betrixaban available to acute medically ill patients in Europe who are at risk for VTE.”
The European Medicines Agency’s Committee for Medicinal Products for Human Use (CHMP) has issued a negative opinion recommending refusal of marketing authorization for the factor Xa inhibitor betrixaban (Dexxience).
Portola Pharmaceuticals, Inc. is seeking approval of betrixaban for the prevention of venous thromboembolism (VTE) in adults hospitalized for an acute medical illness with risk factors for VTE, including VTE-related death.
The marketing authorization application for betrixaban was supported by data from the phase 3 APEX study. In this study, researchers compared oral betrixaban to injectable enoxaparin for the prevention of VTE in patients with acute medical illnesses.
The CHMP said APEX did not satisfactorily show that betrixaban’s benefits outweigh its risk in this patient population. The study results were not considered reliable because some test results for VTEs were not available.
In addition, patients treated with betrixaban had more episodes of bleeding than those treated with enoxaparin. This was considered an important concern given that betrixaban was expected to be used in patients with serious underlying conditions.
For these reasons, the CHMP recommended that betrixaban be refused marketing authorization.
Portola Pharmaceuticals said it intends to appeal the CHMP’s opinion and ask the committee for a re-examination.
“We believe we have generated substantial evidence which demonstrates the clinically meaningful benefit of betrixaban in reducing VTE and VTE-related deaths in this vulnerable patient population, and we remain confident in its potential to have a major public health impact,” said Jack Lawrence, MD, chief medical officer of Portola Pharmaceuticals.
“The re-examination process allows us the opportunity to address the CHMP’s questions and provide further clarification as needed, with the goal of making betrixaban available to acute medically ill patients in Europe who are at risk for VTE.”
The European Medicines Agency’s Committee for Medicinal Products for Human Use (CHMP) has issued a negative opinion recommending refusal of marketing authorization for the factor Xa inhibitor betrixaban (Dexxience).
Portola Pharmaceuticals, Inc. is seeking approval of betrixaban for the prevention of venous thromboembolism (VTE) in adults hospitalized for an acute medical illness with risk factors for VTE, including VTE-related death.
The marketing authorization application for betrixaban was supported by data from the phase 3 APEX study. In this study, researchers compared oral betrixaban to injectable enoxaparin for the prevention of VTE in patients with acute medical illnesses.
The CHMP said APEX did not satisfactorily show that betrixaban’s benefits outweigh its risk in this patient population. The study results were not considered reliable because some test results for VTEs were not available.
In addition, patients treated with betrixaban had more episodes of bleeding than those treated with enoxaparin. This was considered an important concern given that betrixaban was expected to be used in patients with serious underlying conditions.
For these reasons, the CHMP recommended that betrixaban be refused marketing authorization.
Portola Pharmaceuticals said it intends to appeal the CHMP’s opinion and ask the committee for a re-examination.
“We believe we have generated substantial evidence which demonstrates the clinically meaningful benefit of betrixaban in reducing VTE and VTE-related deaths in this vulnerable patient population, and we remain confident in its potential to have a major public health impact,” said Jack Lawrence, MD, chief medical officer of Portola Pharmaceuticals.
“The re-examination process allows us the opportunity to address the CHMP’s questions and provide further clarification as needed, with the goal of making betrixaban available to acute medically ill patients in Europe who are at risk for VTE.”