On September 23, 2016, the FDA approved adalimumab-atto (Amjevita; Amgen) as a biosimilar to adalimumab (Humira; AbbVie) for the treatment of several indications and inflammatory diseases in adults, including moderate-to-severe rheumatoid arthritis; psoriatic arthritis; ankylosing spondylitis; moderate-to-severe Crohn’s disease; moderate-to-severe ulcerative colitis; and moderate-to-severe plaque psoriasis.
Cosentyx (Secukinumab): First IL-17A Antagonist Receives FDA Approval for Moderate-to-Severe Plaque Psoriasis
Defitelio (Defibrotide Sodium): First Drug Approved for Patients with Hepatic Veno-Occlusive Disease
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.
The FDA approved a first-of-its-kind device, Medtronic’s MiniMed 670G hybrid closed looped system, that will automatically monitor glucose and provide basal insulin doses in patients aged ≥14 years with type 1 diabetes. The MiniMed 670G hybrid closed looped system acts as an artificial pancreas, with little or no input needed from the user.
Keytruda (Pembrolizumab) First PD-1 Inhibitor Approved for the Treatment of Patients with Metastatic Non–Small-Cell Lung Cancer Expressing PD-L1
Venclexta (Venetoclax) First BCL-2 Inhibitor Approved for High-Risk Relapsed Chronic Lymphocytic Leukemia
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