NEW YORK—Between a European approval of an oral anticoagulant, an FDA approval of pancreatic neuroendocrine tumor drug and positive trial findings related to a steroid nucleus-based mineralcorticoid receptor antagonist, Pfizer Inc. entered late May with plenty of good news.
First, the European Commission approved Eliquis in the 27 countries of the European Union (EU) for the prevention of venous thromboembolic events (VTE) in adult patients who have undergone elective hip or knee replacement surgery. This decision marks the first approval for Eliquis, a new oral direct Factor Xa inhibitor being developed by the alliance of Bristol-Myers Squibb Co. and Pfizer.
The approval of Eliquis is based on the ADVANCE-2 and ADVANCE-3 clinical trials, which were both part of the EXPANSE clinical trial program. In these trials, Eliquis administered orally twice daily reportedly had superior efficacy versus enoxaparin 40 mg given once daily by injection in the prevention of VTE in total knee and total hip replacement. Moreover, Eliquis didn't increase the risk of bleeding versus enoxaparin.
Eliquis is the only oral anticoagulant with a 12- to 24-hour post surgery initiation window, which is seen as a positive because that may help physicians to observe and stabilize post-surgical patients before beginning treatment. According to Pfizer and Bristol-Myers, Eliquis is dosed 2.5 mg twice daily, requires no routine platelet or liver monitoring and requires no dose adjustment in indicated patients. In patients undergoing hip replacement surgery, the recommended duration of treatment is 32 to 38 days. In patients undergoing knee replacement surgery, the recommended duration of treatment is 10 to 14 days.
"As the first Eliquis approval worldwide, today marks an important milestone for the Bristol-Myers Squibb/Pfizer Alliance," says Beatrice Cazala, senior vice president of commercial operations and president of global commercialization for Europe and emerging markets at Bristol-Myers Squibb. "We are confident that our shared resources and leadership in the treatment of cardiovascular disease will help make the European launch a success and continue to bring value to the development of Eliquis."
"The approval of Eliquis provides a new oral option for patients in the EU undergoing elective hip or knee replacement surgery, where the risk of bleeding is a significant concern," adds Olivier Brandicourt, president and general manager of primary care at Pfizer. "We are excited to bring this new agent to market in Europe and provide orthopedic surgeons with an option that will help them to prevent VTE in patients undergoing elective total knee or total hip replacement surgery."
Next came news that the Pfizer drug Sutent (sunitinib) had been approved for the treatment of advanced pancreatic neuroendocrine tumors by the U.S. Food and Drug Administration (FDA).
The FDA approval of Sutent, and of Afinitor (from Novartis) just two weeks earlier, "is a significant step forward for patients with pancreatic neuroendocrine tumors," says Julie Fleshman, president and CEO of the Pancreatic Cancer Action Network. "Treatment options for pancreatic neuroendocrine tumors have not been well-established, so the news of two new drugs approved by the FDA is exciting."
Sutent had previously been approved for treating other cancer types—specifically gastrointestinal stromal tumor and advanced renal cell carcinoma—but it needed to be tested specifically in patients with pancreatic neuroendocrine tumors. As such, to gain approval, Sutent underwent clinical trials in the United States and several other countries to show that the drug was effective and safe for patients with pancreatic neuroendocrine tumors.
Finally, Pfizer announced on May 22 results from a sub-analysis of the EMPHASIS-HF trial which showed that Inspra (eplerenone), when added to standard recommended therapy, significantly reduced the incidence of new onset atrial fibrillation or flutter (AF/F) in patients with systolic heart failure and mild symptoms, compared with placebo plus standard therapy. This sub-analysis was a pre-specified secondary endpoint in the EMPHASIS-HF study.
