After it was announced that the FDA is going to delay approving Apixaban as a stroke prevention medication for AF patients while the agency gains more information, the move has prompted reassuring words from those who are connected to the drug.
The announcement of the delay came on June 25. Heartwire reported that the companies that are developing the new drug had gotten a complete response letter (CRL) from the FDA asking for more information on “data management and verification” from the ARISTOTLE trial. As soon as the CRL was released, Dr. Robert Califf of the Duke Clinical Research Institute (DCRI) wrote about the decision in his blog. He wanted to make sure that it was clear that the DCRI had nothing really to do with the situation.
“I have spoken with Chris Granger and Lars Wallentin, the co-PIs [of ARISTOTLE],” Califf writes. “While DCRI did not do the data management or monitoring for this trial, we have a copy of the database, and our statisticians have performed the independent analyses. Chris and Lars have assured me that all the essential elements of a quality clinical trial are in place and robust.”
At the same time, the main investigators for the AVERROES study, which is a huge part of the FDA’s deliberations, have sent a note to the trial’s investigators as a means of getting rid of their concerns also.
“The response of the FDA appears to be unrelated to the trial results of AVERROES or ARISTOTLE,” also notes a letter from Drs. Stuart Connolly, Salim Yusuf and John Eikelboom of Canada’s McMaster University. “We would like to emphasize that we have complete confidence in the data of AVERROES and ARISTOTLE showing that Apixaban is effective and safe for the treatment of a broad spectrum of patients with atrial fibrillation. We believe, as do the sponsors, that the issues raised by the FDA will be successfully resolved.”
This delay of approval of Apixaban may cause some annoyance to patients and doctors who are looking for alternatives to more dangerous anticoagulant medications like Multaq. Multaq has been proven to cause serious and potentially deadly side effects including liver failure and a worsening of the heart condition. A PALLAS study even had to be halted because the drug was killing patients who were taking the drug as a treatment for permanent AF.
If you or a loved one have developed liver failure or a worsening of your heart condition after taking Multaq, contact attorney Greg Jones today for a free consultation. I am experienced at fighting Multaq lawsuits and may be able to help you recover money for your injuries.