In the News

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.
The year 2015 was interesting for new drug approvals. As was the case in the recent past, these approvals were dominated by specialty drugs, many of which were first-in-class therapies.
  1. New Pharmaceuticals: New Molecular Entities and New Biologic License Applications
  2. New Combinations and New Indications
  3. New Dosage Forms and New Formulations
  4. 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).
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).
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.
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.
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.
Heart failure affects an estimated 5.7 million patients aged ≥20 years in the United States, according to the 2009-2012 National Health and Nutrition Examination Survey. Approximately 870,000 new cases of heart failure occur annually. Heart failure is projected to affect more than 8 million individuals aged ≥18 years in the United States by 2030, representing a 46% increase from 2012.
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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