Even with the ongoing issues surrounding the anticoagulant drug Xarelto, Janssen Pharmaceutica and its parent company Johnson & Johnson have been very aggressive in their efforts to increase the number of medical conditions to be included in the treatment using Xarelto. In their latest application, they requested approval for the use of Xarelto in the treatment of acute coronary syndrome or ACS, a condition characterized by symptoms associated with the obstruction of the coronary arteries. In a vote of 10-0, the panel assigned by the Food and Drug Administration (FDA), gave a resounding rejection of the application after a thorough assessment.
Xarelto Linked to Serious Internal Bleeding
It may be noted that this rejection was in no way related to the controversy faced by Xarelto for the severe complications it has caused patients. Thousands of patients have reported suffering serious internal bleeding after using Xarelto. Among the more common conditions suffered by patients that involved internal bleeding are intracranial hemorrhage, epidural hematoma, gastrointestinal hemorrhage, retinal hemorrhage, and adrenal bleeding. These complications have been serious enough that patients, according to http://www.xareltoclassaction.us/, have considered filing Xarelto class action lawsuits with the aim of recovering compensations for these grave injuries.
Panel not Convinced by Supporting Evidence
As reported by online media sources, the committee evaluating the application declared that the supporting evidence used by the petitioners was not enough to deserve an approval. The evidence referred here were the results of the clinical trial named the ATLAS program. Highlighted by the committee was the absence of a number of relevant data in the study submitted to the panel.
Had this application been approved, ACS would have been the seventh medical condition to be covered by the anticoagulant drug Xarelto. Already Xarelto has been the number one drug for the treatment of atrial fibrillation, outselling Pradaxa, its closest competitor. Sales for the first half of 2013 was reported to be around $847 million. This is quite an achievement for a medication that has been barely three years in the market.
Second Rejection by FDA
It was also disclosed that this was the second application by Janssen Pharmaceutica, the first also rejected by the FDA in June 2012. The report suggested that the Johnson & Johnson business unit will pursue with its application considering what is to be gained. The market may be considered very attractive, with the estimated 1.2 million patients hospitalized for acute coronary syndrome every year. With complications already linked to Xarelto, would this mean more patients will be facing risks of suffering serious injuries?
References:
fiercepharma.com/story/fda-advisory-panel-gives-jjs-xarelto-resounding-no-acs
ismp.org/quarterwatch/pdfs/2012Q2.pdf
Xarelto Linked to Serious Internal Bleeding
It may be noted that this rejection was in no way related to the controversy faced by Xarelto for the severe complications it has caused patients. Thousands of patients have reported suffering serious internal bleeding after using Xarelto. Among the more common conditions suffered by patients that involved internal bleeding are intracranial hemorrhage, epidural hematoma, gastrointestinal hemorrhage, retinal hemorrhage, and adrenal bleeding. These complications have been serious enough that patients, according to http://www.xareltoclassaction.us/, have considered filing Xarelto class action lawsuits with the aim of recovering compensations for these grave injuries.
Panel not Convinced by Supporting Evidence
As reported by online media sources, the committee evaluating the application declared that the supporting evidence used by the petitioners was not enough to deserve an approval. The evidence referred here were the results of the clinical trial named the ATLAS program. Highlighted by the committee was the absence of a number of relevant data in the study submitted to the panel.
Had this application been approved, ACS would have been the seventh medical condition to be covered by the anticoagulant drug Xarelto. Already Xarelto has been the number one drug for the treatment of atrial fibrillation, outselling Pradaxa, its closest competitor. Sales for the first half of 2013 was reported to be around $847 million. This is quite an achievement for a medication that has been barely three years in the market.
Second Rejection by FDA
It was also disclosed that this was the second application by Janssen Pharmaceutica, the first also rejected by the FDA in June 2012. The report suggested that the Johnson & Johnson business unit will pursue with its application considering what is to be gained. The market may be considered very attractive, with the estimated 1.2 million patients hospitalized for acute coronary syndrome every year. With complications already linked to Xarelto, would this mean more patients will be facing risks of suffering serious injuries?
References:
fiercepharma.com/story/fda-advisory-panel-gives-jjs-xarelto-resounding-no-acs
ismp.org/quarterwatch/pdfs/2012Q2.pdf