|Merck, Bristol-Myers, and Pfizer announced the FDA approved a sNDA for Eliquis|
|By Staff and Wire Reports|
|Friday, 14 March 2014 18:55|
Merck (NYSE: MRK), known as MSD outside the United States and Canada, today announced that the U.S. Food and Drug Administration has approved NOXAFIL® (posaconazole) injection (18 mg/ mL), a new formulation of NOXAFIL for intravenous (IV) use. Merck's antifungal agent is also marketed as NOXAFIL (100 mg) delayed-release tablets and NOXAFIL (40 mg/mL) oral suspension. NOXAFIL injection, delayed-release tablets and oral suspension are indicated for prophylaxis of invasive Aspergillus and Candida infections in patients who are at high risk of developing these infections due to being severely immunocompromised, such as hematopoietic stem cell transplant (HSCT) recipients with graft-versus-host disease (GVHD) or those with hematologic malignancies with prolonged neutropenia (low white blood cell counts) from chemotherapy. NOXAFIL injection is indicated in patients 18 years of age and older.
NOXAFIL delayed-release tablets and oral suspension are indicated in patients 13 years of age and older. With this approval, Merck now provides an IV formulation and two oral formulations of NOXAFIL for prophylaxis against invasive Aspergillus and Candida infections in high-risk patients.
NOXAFIL should not be administered to persons allergic to posaconazole or other azole antifungal medicines. The administration of NOXAFIL with sirolimus, pimozide, quinidine, atorvastatin, lovastatin, simvastatin and ergot alkaloids must be avoided. When administered with NOXAFIL, some drugs such as cyclosporine and tacrolimus required dosage adjustments and frequent monitoring of their levels in the blood as serious side effects in the kidney (nephrotoxicity) or brain (leukoencephalopathy) including deaths have been reported in patients with increased cyclosporine or tacrolimus blood levels. NOXAFIL should be administered with caution to patients who may develop an irregular heart rhythm as NOXAFIL has been shown to prolong the QT interval and cases of potentially fatal irregular heart rhythm (torsades de pointes) have been reported in patients taking NOXAFIL (posaconazole). (See Selected Safety Information below.)
“Merck is pleased to add NOXAFIL injection to the NOXAFIL family of products. The availability of a NOXAFIL formulation for intravenous administration is particularly important for those patients who may benefit from or require intravenous therapy, or who, for a variety of reasons, might not be able to take an oral formulation. In addition, patients have the possibility to start on NOXAFIL injection and transition to oral NOXAFIL,” said Dr. Nicholas Kartsonis, executive director, Infectious Disease, Merck Research Laboratories.
NOXAFIL injection offers patients once-daily maintenance dosing following a twice-daily loading dose on the first day of NOXAFIL therapy. NOXAFIL injection is administered with a loading dose of 300 mg (one 300 mg vial) twice a day on the first day of NOXAFIL therapy, then 300 mg (one 300 mg vial) once a day thereafter. Once combined with a mixture of intravenous solution (150 mL of 5% dextrose in water or sodium chloride 0.9%), NOXAFIL injection should be immediately administered through an in-line filter. Administer NOXAFIL through a central venous line by slow IV infusion over approximately 90 minutes. If not used immediately, the solution can be stored up to 24 hours refrigerated at 2-8 degrees C (36-46 degrees F). Coadministration of drugs that can decrease the plasma concentration of posaconazole should generally be avoided unless the benefit outweighs the risk. If such drugs are necessary, patients should be monitored closely for breakthrough fungal infections.
In clinical trials, the adverse reactions reported for NOXAFIL IV injection were generally similar in type to that reported in trials of NOXAFIL oral suspension. The most frequently reported adverse reactions with an onset during the posaconazole intravenous phase of dosing 300 mg once-daily therapy were diarrhea (32%), hypokalemia (22%), fever (21%) and nausea (19%).
NOXAFIL injection is expected to be available at wholesalers in mid-April.
Bristol-Myers Squibb Company (NYSE: BMY) and Pfizer Inc. (NYSE: PFE) today announced that the U.S. Food and Drug Administration (FDA) approved a Supplemental New Drug Application (sNDA) for Eliquis (apixaban) for the prophylaxis of deep vein thrombosis (DVT), which may lead to pulmonary embolism (PE), in patients who have undergone hip or knee replacement surgery.
Todays FDA approval of Eliquis for DVT prophylaxis in patients who have undergone hip or knee replacement is a significant milestone for this important medicine, which is also approved to reduce the risk of stroke and systemic embolism in patients with nonvalvular atrial fibrillation, said Brian Daniels, M.D., senior vice president, global development and medical affairs, Bristol-Myers Squibb (BMY). This approval reflects the continued commitment of the alliance to deliver new treatment options for patients and physicians.
As the number of hip and knee replacement surgeries performed in the U.S. continues to increase, the risk of DVT following these surgeries remains a concern for physicians, said Steven J. Romano, M.D., senior vice president and Medicines Development Group Head, Global Innovative Pharmaceuticals Business, Pfizer Inc. (PFE) Eliquis provides patients and physicians with a new treatment option that offers twice daily oral dosing and no routine coagulation testing, and is broadly accessible through hospitals and managed health care formularies.
The full Prescribing Information for Eliquis includes Boxed Warnings for the increased risk of stroke in patients with nonvalvular atrial fibrillation who discontinue Eliquis without adequate continuous anticoagulation; and for the increased risk of epidural or spinal hematoma, which may cause long-term or permanent paralysis, in patients using Eliquis and undergoing spinal epidural anesthesia or spinal puncture. Please see complete Boxed Warnings and additional Important Safety Information in this press release.
DVT, a blood clot that forms in a large vein, usually in the lower leg, thigh, or pelvis, can lead to PE when a portion or all of a blood clot breaks off and travels to the lungs, blocking one or more blood vessels. PE can lead to sudden death.
Based on recent data, each year in the U.S. an estimated 719,000 total knee replacement surgeries and 332,000 hip replacement surgeries are performed. Patients undergoing hip or knee replacement surgery without thromboprophylaxis are at risk for developing DVT and PE.Guidelines recommend the use of anticoagulants for the prophylaxis of DVT and PE for most patients undergoing orthopedic surgery.
DVT, which may lead to PE, is a serious medical condition,said Richard J. Friedman, M.D., FRCSC, Professor of Orthopaedic Surgery, Medical University of South Carolina. The FDA approval of Eliquis gives U.S. orthopedic surgeons a new option for DVT prophylaxis in both hip and knee replacement surgery.
This sNDA approval for Eliquis is supported by three clinical trials (the ADVANCE clinical trial program). The ADVANCE trials randomized more than 11,000 patients, with 5,770 receiving Eliquis and 5,755 receiving enoxaparin, to assess the safety and efficacy of Eliquis.
In December 2013, the FDA accepted for review another sNDA for Eliquis for the treatment of DVT and PE, and for the reduction in the risk of recurrent DVT and PE.
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