In the News
On March 11, 2016, the US Food and Drug Administration (FDA) approved an expanded indication for crizotinib (Xalkori; Pfizer) for the treatment of patients with metastatic non−small-cell lung cancer (NSCLC) that harbors the ROS-1 genetic mutation. Crizotinib is the first and only FDA-approved treatment for this patient population; the drug blocks ROS-1 protein activity in tumors, with the potential to prevent NSCLC tumors from spreading.
On March 4, 2016, the US Food and Drug Administration (FDA) approved a new type of coagulation factor IX (recombinant), albumin fusion protein (Idelvion; CSL Behring), for use in children and adults with hemophilia B. Used to replace a naturally occurring clotting factor functionally deficient or defective in these patients, this is the first coagulation factor-albumin fusion protein drug to be approved by the FDA.
American Health & Drug Benefits publishes a Payers' Guide to New FDA Approvals annually with the goal of providing payers and other healthcare stakeholders a comprehensive review of pharmaceuticals that were newly approved or that received important new indications by the US Food and Drug Administration (FDA) in the previous year.
- New Pharmaceuticals: New Molecular Entities and New Biologic License Applications
- New Combinations and New Indications
- New Dosage Forms and New Formulations
- New Biosimilars, Vaccines, Viral Therapies, and Blood Products
The year 2015 brought important advances in the treatment of multiple myeloma. Most impressive was the US Food and Drug Administration (FDA) approval of 4 novel agents—panobinostat (Farydak), daratumumab (Darzalex), elotuzumab (Empliciti), and ixazomib (Ninlaro)—as well as new indications for 3 drugs already on the market—lenalidomide (Revlimid), carfilzomib (Kyprolis), and pomalidomide (Pomalyst).
Aripiprazole Lauroxil (Aristada): Long-Acting Atypical Antipsychotic Injection Approved for the Treatment of Patients with Schizophrenia
Schizophrenia is a chronic brain disorder that affects approximately 1% of the US adult population.1 Schizophrenia is characterized by positive, negative, and cognitive symptoms. Positive symptoms include delusions, hallucinations (eg, hearing voices), and paranoia (eg, the belief that others are controlling your thoughts).
Corlanor (Ivabradine), First HCN Channel Blocker, FDA Approved for the Treatment of Patients with Heart Failure
Heart failure is a life-threatening condition that affects approximately 5.7 million individuals aged ≥20 years in the United States. With an estimated 870,000 new cases of heart failure occurring annually, heart failure is expected to affect more than 8 million people aged ≥18 years by 2030—an alarming 46% increase from 2012.
Cosentyx (Secukinumab): First IL-17A Antagonist Receives FDA Approval for Moderate-to-Severe Plaque Psoriasis
Psoriasis, the most prevalent autoimmune disease in the United States, affects approximately 7.5 million people. A chronic, relapsing disease, psoriasis is characterized by thick patches of inflamed scaly skin resulting from excessive proliferation of skin cells.
Darzalex (Daratumumab): First Anti-CD38 Monoclonal Antibody Approved for Patients with Relapsed Multiple Myeloma
Multiple myeloma is a cancer of plasma cells in the bone marrow that often leads to bone destruction and bone marrow failure. According to the American Cancer Society, more than 26,800 new cases of multiple myeloma were diagnosed in 2015, and 11,240 deaths were attributed to the disease.
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Results 41 - 50 of 116