FDA Actions
The FDA has approved idarucizumab, the first reversal agent for dabigatran (Pradaxa) and the first reversal agent for any of the new oral anticoagulants. Idarucizumab is a humanized monoclonal antibody fragment that binds to the drug and neutralizes its effect. The safety and efficacy of the drug were studied in three trials of nearly 300 healthy volunteers taking dabigatran. The effect of the drug after IV infusion was almost immediate and lasted at least 24 hours. In a trial of 123 patients (90 with available data) taking dabigatran and presenting with uncontrolled bleeding or needing emergent surgery, the effect of dabigatran was completely reversed in 89% within 4 hours of receiving idarucizumab. Dabigatran is approved for stroke prevention in patients with non-valvular atrial fibrillation, treatment of deep venous thrombosis/pulmonary embolism, and prevention of recurrent deep venous thrombosis/pulmonary embolism. Reversal of dabigatran exposes patients to increased risk of clotting from their underlying disease. Idarucizumab and dabigatran are both marketed by Boehringer Ingelheim. Idarucizumab will be marketed as Praxbind and is expected to be available by November at a price of $3500 per dose. The availability of a reversal agent may give dabigatran a leg up in the competitive new anticoagulant market. A reversal agent for the other new oral anticoagulants (rivaroxaban [Xarelto], apixaban [Eliquis], and edoxaban [Savaysa]) is under study, but is still at least 1 year from approval.
The FDA has approved a long-acting version of aripiprazole (Abilify) to treat adults with schizophrenia. The new formulation is an extended-release intramuscular injection administered by a healthcare professional every 4-6 weeks. The efficacy of extended-release aripiprazole was shown in a 12-week clinical trial of 620 participants with schizophrenia who had been stabilized on oral aripiprazole, where the drug was shown to maintain treatment effect compared to placebo. Like other antipsychotic drugs, aripiprazole carries a boxed warning for healthcare professionals about increased risk of death associated with off-label use of the drugs in older patients with dementia-related psychosis. Extended-release aripiprazole is manufactured by Alkermes as Aristada and will cost approximately $1500 per month. This new formulation will compete with Abilify Maintena, a once-monthly injectable version of aripiprazole from Otsuka Pharmaceutical. Oral Abilify lost its patent protection and became generic in April 2015.
The FDA is warning that the recently approved combination treatments for chronic hepatitis C can cause serious liver damage, mostly in patients with advanced liver disease. The two products are ombitasvir, paritaprevir, and ritonavir tablets co-packaged with dasabuvir tablets, (marketed as Viekira Pak) for the treatment of HCV genotype 1, and ombitasvir, paritaprevir, and ritonavir (marketed as Technivie) for the treatment of HCV genotype 4. Since approval about 1 year ago, there have been at least 26 worldwide cases of liver injury occurring within 1-4 weeks of starting treatment. It is recommended that healthcare professionals closely monitor for signs and symptoms of worsening liver disease when initiating these medications. This new warning, coupled with the high pill burden associated with these drugs, may move market share toward other available agents for the treatment of chronic HCV infections.
The FDA has approved a new oral suspension to treat hyperkalemia. Patiromer is a powder mixed with water and taken orally. The drug binds potassium in the gastrointestinal tract, decreasing absorption. In clinical trials patiromer was effective in lowering potassium levels in hyperkalemic patients with chronic kidney disease on at least one drug that inhibited the renin-angiotensin-aldosterone system. The drug is not recommended for emergency treatment of severe hyperkalemia. Patiromer also binds other orally administered drugs, which could decrease absorption. Therefore, administration of other drugs should be delayed by at least 6 hours after administration. Patiromer is manufactured by Relypsa as Veltressa. The drug is expected to cost nearly $600 for a 30-day supply.
The FDA has a approved the first oncolytic virus for the treatment of melanoma. Talimogene laherparepvec is a genetically modified live herpes simplex virus type 1 that is injected directly into tumors where it replicates and causes cells to rupture and die. A second dose is administered 3 weeks later followed by additional doses every 2 weeks for at least 6 months unless other treatment is required or until there are no remaining injectable lesions to treat. In a study of 436 participants with metastatic melanoma, 16.3% of study participants experienced a decrease in size of the skin and lymph node lesions lasting at least 6 months compared to 2.1% on comparator therapy. Overall survival, however, did not improve, and there was no improvement in lesions that had spread to the brain, bones, liver, lungs, or other internal organs. Because it is a live virus with potential to cause herpes virus infection, talimogene laherparepvec should not be given to immunosuppressed individuals or those who are pregnant. Talimogene laherparepvec is manufactured by BioVex, a subsidiary of Amgen, as Imlygic and is expected to cost $65,000 per treatment course.
FDA approves reversal agents, signs off on schizophrenia drug, warns of liver damage associated with hepatitis C treatment, green lights hyperkalemia treatment, and approves the first oncolytic virus for the treatment of melanoma.
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