Pfizer and Bristol-Myers Squibb have been boosted by the news that the European Commission has given the thumbs-up to their blood thinner Eliquis to prevent clots after surgery to replace hips or knees.
Specifically, Eliquis (apixaban) has been approved for the prevention of venous thromboembolic events (VTE) in adults who have undergone elective hip or knee replacement surgery. The decision by the European authorities marks the first approval for the new oral direct Factor Xa inhibitor.
The green light was widely expected given that the European Medicines Agency’s Committee for Medicinal Products for Human Use recommended approval in March. The approval is based on the ADVANCE-2 and ADVANCE-3 clinical trials which showed that Eliquis given orally twice-daily demonstrated superior efficacy versus Sanofi's Lovenox (enoxaparin 40 mg given once-daily by injection in the prevention of VTE in total knee and total hip replacement.
The trials, which randomised over 8,000 patients. also showed that Eliquis did not increase the risk of bleeding versus Lovenox. Pfizer and B-MS also noted that the drug is the only oral anticoagulant with a 12- to 24-hour post surgery initiation window, "which may help physicians to observe and stabilize post-surgical patients before beginning treatment".
Beatrice Cazala, president of global commercialisation in Europe and the emerging markets at B-MS, said the partners 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 is for a small indication but the clinical trial programme for Eliquis, which should include nearly 60,000 patients, is exploring multiple indications, notably the prevention of stroke and other thromboembolic events in patients with atrial fibrillation. The drug will go up against Boehringer Ingelheim’s Pradaxa (dagibatran), which received a positive recommendation from the CHMP for the prevention of stroke and systemic embolism in adults with nonvalvular atrial fibrillation last month, and Bayer's Xarelto (rivaroxaban).
Sutent approved for rare pancreas cancer
Pfizer also had cause to celebrate getting a new approval in the USA for its cancer treatment Sutent.
The US Food and Drug Administration has granted expanded approval to Sutent (sunitinib) for patients with progressive pancreatic neuroendocrine tumours (PNET) with unresectable locally advanced or metastatic disease. The green light is based on a Phase III 171-patient study which showed median progression-free survival of 10.2 months in patients receiving Sutent compared to 5.4 months for the placebo group.
PNET is a rare cancer reported in two to four people per million annually worldwide, Pfizer noted. Sutent is already approved for advanced kidney cancer and gastrointestinal stromal tumours after disease progression on or intolerance to Novartis' Glivec (imatinib).