Category Archives: Drug Update

Hairy cell leukemia (HCL) is a rare, slow-growing cancer of the blood in which the bone marrow produces too many abnormal B cells or lymphocytes. This compromises the bone marrow’s ability to produce healthy blood cells and platelets. Patients with HCL may experience enlargement of the spleen, increased susceptibility to life-threatening conditions such as infections […]

Hereditary angioedema (HAE) is a disease characterized by recurrent and debilitating attacks of angioedema, or severe swelling of the limbs, airway, face, or intestinal tract. HAE affects about one in 10,000 to 50,000 individuals worldwide and can have a significant impact on quality of life. There are currently six FDA-approved therapies available for individuals with […]

Generic Name Brand Name Manufacturer Approval Date Anticipated Availability Accelerated Review filgrastim-aafi Nivestym ™ Pfizer Inc. 07/20/2018 n/a n/a Labeled Indications Decrease the incidence of infection‚ as manifested by febrile neutropenia‚ in patients with non-myeloid malignancies receiving myelosuppressive anti-cancer drugs associated with a significant incidence of severe neutropenia with fever Reduce the time to neutrophil […]

Familial chylomicronemia Syndrome (FCS) is a genetic disorder characterized by impaired function of the enzyme lipoprotein lipase (LPL), leading to the inability to break down chylomicrons and the buildup of chylomicrons in the blood. Chylomicrons are lipoprotein particles primarily made up of triglycerides. This buildup results in a significant increase in triglyceride levels, severe abdominal […]

Hereditary transthyretin (TTR)-mediated amyloidosis (hATTR) is an inherited and debilitating disease that is characterized by mutations in the TTR gene. These gene mutations can cause accumulation of abnormal amyloid proteins in body organs and tissue, leading to damage of these areas, such as the peripheral nerves. Peripheral, autonomic, or cardiomyopathy can result from this accumulation […]

New Drug Overview: Pegfilgrastim-jmdb (Fulphila™) The first FDA approved biosimilar to Pegfilgrastim (Neulasta®) Generic Name Brand Name Manufacturer Approval Date Anticipated Availability Accelerated Review Pegfilgrastim-jmdb Fulphila ™ Mylan GmbH June 4, 2018 In the coming weeks n/a Labeled Indication: Decrease the incidence of infection, as manifested by febrile neutropenia, in patients with non-myeloid malignancies receiving […]

Migraine is a debilitating disorder that affects millions of people in the United States. Migraine has the ability to affect individuals in a way that deprives them of their normal, daily activities, and often results in pain, physical impairment, lost productivity, and increased financial cost. Fremanezumab (TEV-48125), developed by Teva Pharmaceutical Industries Ltd., is a […]

Mogamulizumab is a humanized monoclonal antibody being developed by Kyowa Hakko Kirin Co., Ltd. for the treatment of cutaneous and peripheral T-cell lymphomas, T-cell leukemia, and T-cell lymphomas. Mogamulizumab has shown promising efficacy in treating Cutaneous T-Cell Lymphoma (CTCL) in a phase III trial. The FDA granted mogamulizumab a Breakthrough Therapy Designation on August 25, […]

New Drug Overview: Epoetin alfa-epbx (Retacrit®) Generic Name Brand Name Manufacturer Approval Date Anticipated Availability Accelerated Review Epoetin alfa-epbx Retacrit ® Hospira Inc., a Pfizer company May 15, 2018 Not available n/a Labeled Indications: For the treatment of anemia caused by Chronic Kidney Disease (CKD) in patients on dialysis and not on dialysis For the […]

Migraine is a debilitating disorder that affects millions of people in the United States. Migraine has the ability to affect individuals in a way that deprives them of their normal, daily activities, and often results in pain, physical impairment, lost productivity, and increased financial cost. Erenumab (Aimovig™, AMG-334) is a fully human monoclonal antibody being […]