FDA News

Janssen expands Xarelto research program

Janssen Research & Development and Bayer HealthCare announced the expansion of the EXPLORER research program for Xarelto with a series of new clinical trials in high-risk populations.

The new studies will assess Factor Xa inhibitor Xarelto (rivaroxaban) for the treatment of ACS, embolic stroke of indeterminate source and peripheral artery disease, according to a Janssen press release. The company may seek FDA approval for Xarelto for these indications if the trial results are favorable.

With the program expansion, EXPLORER now encompasses 17 phase 3 trials, including 10 completed studies, according to the release. Upon completion of the entire rivaroxaban program, EXPLORER will have included over 275,000 patients, 151,000 of whom will have been participants in controlled, randomized studies.

The following new trials will be part of the expansion of the EXPLORER program, according to the release:

  • GEMINI 1 & 2 ACS, which will assess Xarelto among patients with ACS. The phase 2 GEMINI 1 ACS trial will initiate this program, with an evaluation of rivaroxaban combined with a single antiplatelet agent for the prevention of additional CV events in a population of 2,000-3,000 patients collected from more than 10 countries. The global, phase 3 GEMINI 2 ACS trial will follow GEMINI 1 in the event of success.
  • NAVIGATE ESUS, a global, phase 3 indication-seeking trial of at least 7,000 patients from over 25 countries. This study will assess Xarelto as a treatment for embolic stroke of undetermined source.
  • VOYAGER PAD, also a global, phase 3 indication-seeking trial. This study, which will include at least 5,000 patients from over 20 countries, will assess Xarelto in a cohort of patients with PAD who are undergoing peripheral artery interventions.

The program expansion follows two rejections by the FDA’s Cardiovascular and Renal Drugs Advisory Committee for the use of rivaroxaban as a treatment for ACS. In May 2012, the committee voted 4-6 against recommendation of the expanded indication, citing insufficient data on early withdrawal and death among recipients. In early 2014, the committee again voted against recommending Xarelto for the prevention of CV-related mortality, MI and stroke within 90 days of ACS onset, due to a lack of convincing data on the benefits of the treatment outweighing bleeding risks.

Xarelto is currently approved for the treatment of deep vein thrombosis and pulmonary embolism, the reduction of risk for recurrence of DVT or PE after treatment for acute venous thromboembolism, for the reduction of risk for stroke and blood clots in patients with atrial fibrillation due to causes other than heart valve issues, and for the reduction of risk for blood clots in the legs and lungs of patients who have undergone knee or hip replacement surgery.

Janssen Research & Development and Bayer HealthCare announced the expansion of the EXPLORER research program for Xarelto with a series of new clinical trials in high-risk populations.

The new studies will assess Factor Xa inhibitor Xarelto (rivaroxaban) for the treatment of ACS, embolic stroke of indeterminate source and peripheral artery disease, according to a Janssen press release. The company may seek FDA approval for Xarelto for these indications if the trial results are favorable.

With the program expansion, EXPLORER now encompasses 17 phase 3 trials, including 10 completed studies, according to the release. Upon completion of the entire rivaroxaban program, EXPLORER will have included over 275,000 patients, 151,000 of whom will have been participants in controlled, randomized studies.

The following new trials will be part of the expansion of the EXPLORER program, according to the release:

  • GEMINI 1 & 2 ACS, which will assess Xarelto among patients with ACS. The phase 2 GEMINI 1 ACS trial will initiate this program, with an evaluation of rivaroxaban combined with a single antiplatelet agent for the prevention of additional CV events in a population of 2,000-3,000 patients collected from more than 10 countries. The global, phase 3 GEMINI 2 ACS trial will follow GEMINI 1 in the event of success.
  • NAVIGATE ESUS, a global, phase 3 indication-seeking trial of at least 7,000 patients from over 25 countries. This study will assess Xarelto as a treatment for embolic stroke of undetermined source.
  • VOYAGER PAD, also a global, phase 3 indication-seeking trial. This study, which will include at least 5,000 patients from over 20 countries, will assess Xarelto in a cohort of patients with PAD who are undergoing peripheral artery interventions.

The program expansion follows two rejections by the FDA’s Cardiovascular and Renal Drugs Advisory Committee for the use of rivaroxaban as a treatment for ACS. In May 2012, the committee voted 4-6 against recommendation of the expanded indication, citing insufficient data on early withdrawal and death among recipients. In early 2014, the committee again voted against recommending Xarelto for the prevention of CV-related mortality, MI and stroke within 90 days of ACS onset, due to a lack of convincing data on the benefits of the treatment outweighing bleeding risks.

Xarelto is currently approved for the treatment of deep vein thrombosis and pulmonary embolism, the reduction of risk for recurrence of DVT or PE after treatment for acute venous thromboembolism, for the reduction of risk for stroke and blood clots in patients with atrial fibrillation due to causes other than heart valve issues, and for the reduction of risk for blood clots in the legs and lungs of patients who have undergone knee or hip replacement surgery.