In the News
Breo Ellipta: A Fixed-Dose Combination Oral Inhaler Receives FDA Approval for Long-Term Maintenance Treatment of COPD
Chronic obstructive pulmonary disease (COPD) is a common, life-threatening disease characterized by a persistent blockage of airflow from the lungs. COPD encompasses a range of chronic obstructive lung diseases, including chronic bronchitis and emphysema.
Invokana (Canagliflozin): First-in-Class SGLT2 Inhibitor Approved for the Treatment of Type 2 Diabetes
Diabetes affects an estimated 25.8 million people in the United States—a staggering 8.3% of the population. In addition, 35% of US adults have prediabetes and are at high risk for developing diabetes. Coinciding with the aging of the US population, the prevalence of diabetes is projected to increase dramatically over the next few decades, from approximately 1 of 10 adults today to approximately 1 of 3 adults by 2050. Approximately 90% to 95% of all cases of diabetes are type 2 diabetes mellitus, and approximately 5% are type 1 diabetes mellitus.
Nesina, Kazano, and Oseni: Three Alogliptin-Based Agents Approved for the Treatment of Type 2 Diabetes
Diabetes affects an estimated 25.8 million people in the United States—a staggering 8.3% of the population. Type 2 diabetes accounts for 90% to 95% of all adult cases of diabetes. In addition, an estimated 35% of US adults aged ≥20 years have prediabetes, and the prevalence of prediabetes jumps to 50% in adults aged ≥65 years.
Tafinlar and Mekinist: Two Oral Targeted Kinase Inhibitors for the Treatment of Patients with Metastatic Melanoma and BRAF Mutations
Cutaneous melanoma, although not the most common skin cancer, is the most deadly. Based on data collected between 2003 and 2009, the 5-year survival rate for Americans with metastatic melanoma remains very low—only 16%—for all disease stages and for both sexes. The National Cancer Institute has estimated that approximately 1 in 49 people will be diagnosed with melanoma in the United States, and more than 9450 people will die of this disease in 2013.
On May 29, 2013, the US Food and Drug Administration (FDA) approved 2 targeted oral therapies for patients with melanoma. The 2 therapies were both developed by GlaxoSmithKline and are targeting similar, but not the same, populations of patients with melanoma and a BRAF mutation. Both drugs were approved concurrently with the FDA approval of a companion diagnostic assay THxID BRAF (manufactured by bioMérieux) for the detection of BRAF V600E and BRAF V600K mutations.
On June 5, 2013, the US Food and Drug Administration (FDA) approved lenalidomide capsules (Revlimid; Celgene Corporation) for the treatment of patients with mantle-cell lymphoma whose disease has relapsed or progressed after 2 previous therapies, one of which included bortezomib (Velcade).
Simbrinza (Brinzolamide/Brimonidine Tartrate) Receives FDA Approval for the Treatment of Open-Angle Glaucoma or Ocular Hypertension
Glaucoma affects an estimated 2.2 million people in the United States, and is estimated to affect as many as 3 million people by 2020.1 Its prevalence is projected to rise with the aging of the US population.2 Glaucoma has the potential to destroy retinal ganglion cells in the optic nerve, which can lead to severe vision loss and blindness.1 In fact, glaucoma is a leading cause of blindness in the United States, accounting for 9% to 12% of all cases of blindness.3
Ilaris (Canakinumab) Receives a New Indication for the Treatment of Systemic Juvenile Idiopathic Arthritis
Systemic juvenile idiopathic arthritis (SJIA) is a rare inflammatory disease, affecting approximately 10% of children diagnosed with juvenile idiopathic arthritis in the United States.1,2 The classic symptoms of SJIA include pain in the small joints of the hands, wrists, knees, and ankles; rash; and a high, spiking fever of ≥103°F that can last for weeks to months.3 By definition, SJIA can present at any point until the age of 16 years.
Xofigo (Radium Ra 223 Dichloride): The First Alpha Particle–Emitting Radioactive Agent for the Treatment of Castration-Resistant Prostate Cancer with Symptomatic Bone Metastases
Prostate cancer is the second leading cause of cancer-related death in the United States among men and the most frequently diagnosed cancer in American males. Among patients with metastatic prostate cancer, up to approximately 90% have bone metastases.1 The median survival after the diagnosis of bone metastasis associated with prostate cancer is approximately 3 years.2
Kadcyla (Ado-Trastuzumab Emtansine): First Antibody-Drug Conjugate Approved for the Treatment of HER2-Positive Metastatic Breast Cancer
Approximately 25% of women who are diagnosed with breast cancer have HER2-positive tumors. The HER2 gene, which resides on chromosome 17, directs tumor cells to manufacture HER2 protein. This protein is a cell-surface receptor that compels the tumor cell to grow and to divide more frequently than normal, making HER2-positive breast cancer an aggressive phenotype.
Before the advent of HER2-directed therapies, patients diagnosed with HER2-positive disease had significantly shorter disease-free survival compared with patients with other breast cancer subtypes.1
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Results 81 - 90 of 104
Results 81 - 90 of 104