In April 2016, venetoclax (Venclexta; Janssen) became the first BCL-2 inhibitor to be approved by the FDA for relapsed, high-risk chronic lymphocytic leukemia.
An estimated 7.5 million people in the United States have psoriasis, a chronic, inflammatory, autoimmune disease.
Urothelial carcinoma (also known as transitional-cell carcinoma) is the most common subtype of bladder cancer, accounting for more than 90% of bladder cancer diagnoses in the United States. In 2016, nearly 77,000 cases of bladder cancer are expected to be diagnosed in the United States, and more than 16,000 people will die from this disease. The incidence of bladder cancer increases with age, with a median age of 73 years at diagnosis.

Chronic lymphocytic leukemia (CLL), a cancer of B-cell lymphocytes, is the most common type of leukemia in adults. According to the American Cancer Society, more than 18,900 Americans will be diagnosed with CLL in 2016.

On March 30, 2016, the FDA approved defibrotide sodium (Defitelio; Jazz Pharmaceuticals) for hepatic veno-occlusive disease (VOD) with renal or pulmonary dysfunction after hematopoietic stem-cell transplant. This is the first drug approved for severe hepatic VOD. “The approval of Defitelio fills a significant need in the transplantation community to treat this rare but frequently fatal complication,” said Richard Pazdur, MD.
Allergic diseases, including asthma, represent the fifth most common chronic diseases in individuals of all ages, and the third most common chronic diseases in children.
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).
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