Johnson & Johnson has filed its response to the US FDA in an attempt to answer the agency's concerns about use of its Xarelto anticoagulant to prevent heart attacks and strokes in patients with acute coronary syndrome (ACS).
The FDA sent the company a Complete Response letter in June turning down Xarelto (rivaroxaban) in ACS, largely because of concerns about incomplete record-keeping in the ATLAS ACS 2 TIMI 51 study, which underpinned the drug's marketing application.
The missing data had led an FDA advisory committee to rule earlier in the year that the beneficial effect or Xarelto on mortality in ACS patients was not reliable.
Now, J&J says it has filed its response to the FDA, including "specific information requested by the FDA in their [Complete Response] letter". The company has US rights to sell Xarelto, which was originally developed by Bayer.
The pharma company has also resubmitted a marketing application seeking approval for Xarelto to reduce the risk of stent thrombosis in patients with ACS, also based on data from the ATLAS ACS 2 TIMI 51 study.
Xarelto is already approved for three indications in the US, including prevention of blood clots and other complications in patients undergoing hip and knee replacement surgery and those with atrial fibrillation, but approval in ACS could open up an additional $1bn market for the drug, according to analysts.
If the FDA accepts J&J's response and approves Xarelto for ACS, the drug would become the first new anticoagulant since warfarin to reach the market in this setting.
That could give it a major boost over rival anticoagulants Pradaxa (dabigatran) from Boehringer Ingelheim and Pfizer/Bristol-Myers Squibb's Eliquis (apixaban), which are jostling for market share with J&J's drug in its current indications but failed to win approval in ACS.
"We are confident in the robust study results and the positive benefit risk profile of Xarelto in patients with ACS," said J&J chief executive Alex Gorsky.