The Medicines Company has received a not approvable letter from the FDA on a supplemental New Drug Application for an additional dosing regimen for Angiomax (bivalirudin) in the treatment of acute coronary syndromes initiated in the emergency department.
The FDA indicated that the basis of their decision involved the appropriate use and interpretation of non-inferiority trials, including the ACUITY trial. The Medicines Company said it disagrees with the FDA and has initiated discussions to address the decision.
According to the Parsippany, N.J.-based company, the primary basis of its filing was the ACUITY trial results, which were published in the New England Journal of Medicine, the Journal of the American Medical Association and the Lancet.
The Medicines Company said it continues to believe that the ACUITY results are consistent with those demonstrated in clinical trials of more than 47,000 patients across a broad spectrum of cardiovascular risk, including: REPLACE-2, BAT, and most recently, the HORIZONS-AMI trial. The trials demonstrate that utilizing Angiomax instead of heparin not only provides comparable protection against ischemic events, but also reduces bleeding and costs, the company said.
Despite the setback, the Medicines Company reaffirmed its 2008 Angiomax U.S. sales guidance of $310 million to $320 million. As of March 2008, more than 44 percent of patients undergoing PCI receive Angiomax as their baseline anti-coagulant, according to the company.