A Payers’ Guide to New FDA Approvals is published annually by American Health & Drug Benefits to offer payers and other healthcare stakeholders a detailed analysis of new drugs approved by the US Food and Drug Administration (FDA) in the previous year, as well as a preview of some of the key trends in the 2015 drug pipeline.
There were 41 new drug approvals by the US Food and Drug Administration (FDA) in 2014, the highest number since 1996, when a record 53 new drugs were approved. This number is significantly higher than the 27 drugs approved in 2013. As has been the case for the past 3 years, specialty and orphan drugs dominated the approval list.
Afrezza (Insulin Human) Inhalation Powder Approved for the Treatment of Patients with Type 1 or Type 2 Diabetes
Diabetes is a chronic disease that is often accompanied by multiple comorbidities and health complications. In the United States, diabetes affects an estimated 29.1 million people—approximately 9.3% of the US population. An additional 37% of adults aged ≥20 years are estimated to have prediabetes, based on 2009-2012 data for fasting glucose or glycated hemoglobin (Hb) A1c. Furthermore, with the aging of the US population during the next few decades, the prevalence of diabetes is projected to increase from 1 in 10 adults today to a staggering 1 in 3 adults by 2050.
Akynzeo (Netupitant and Palonosetron), a Dual-Acting Oral Agent, Approved by the FDA for the Prevention of Chemotherapy-Induced Nausea and Vomiting
One of the most fear-inducing side effects of chemotherapy is nausea and vomiting. Without appropriate antiemetic prophylaxis, 70% to 80% of all patients with cancer who receive chemotherapy experience nausea and/or vomiting. Consequently, preventing and managing chemotherapy-induced nausea and vomiting (CINV) is a crucial part of care planning for patients with cancer.
Cyramza (Ramucirumab) Approved for the Treatment of Advanced Gastric Cancer and Metastatic Non–Small-Cell Lung Cancer
Gastric cancer and lung cancer impose a substantial burden on patients. In light of the high mortality rate and quality-of-life issues associated with these 2 types of cancer, there is a marked need for additional therapeutic options to improve outcomes for patients with gastric or lung cancer.
Once-a-Day Harvoni (Ledipasvir plus Sofosbuvir), a New Oral Combination for the Treament of Patients with Genotype 1 Chronic Hepatitis C Infection
Hepatitis C virus (HCV) infection is the most common blood-borne disease; approximately 3.2 million Americans and 130 million to 170 million individuals worldwide are infected with HCV. Chronic HCV infection has been called a silent epidemic; the disease can remain quiescent for decades before clinically significant symptoms appear. Because many Americans who are currently living with HCV were infected before blood screening testing for HCV was performed, the prevalence of HCV complications is likely to rise as these individuals enter their 50s and 60s.
Imbruvica (Ibrutinib), First-in-Class Bruton’s Tyrosine Kinase Inhibitor, Receives Expanded Indications for Patients with Relapsed Chronic Lymphocytic Leukemia
Chronic lymphocytic leukemia (CLL), the most common type of leukemia in adults, is a cancer of B-cell lymphocytes, which originate in the bone marrow, develop in the lymph nodes, and normally fight infection by producing an immune response. In CLL, excess B-cells accumulate in the bone marrow and blood, where they crowd out healthy blood cells.
Invokamet (Canagliflozin plus Metformin HCl): First Fixed-Dose Combination with an SGLT2 Inhibitor Approved for the Treatment of Patients with Type 2 Diabetes
Diabetes is a chronic disease that affects an estimated 29.1 million individuals in the United States—approximately 9.3% of the US population. In addition, a staggering 37% of US adults have prediabetes, placing them at a high risk for 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 in 10 adults today to approximately 1 in 3 adults by 2050. Approximately 90% to 95% of all cases of diabetes are type 2 diabetes mellitus, a disease that is characterized by insulin resistance and a gradual decline in the ability of the pancreas to produce insulin.
Jakafi (Ruxolitinib): First FDA-Approved Medication for the Treatment of Patients with Polycythemia Vera
Similar to myelofibrosis and essential thrombocythemia, polycythemia vera is a Philadelphia chromosome–negative myeloproliferative neoplasm. Polycythemia vera is characterized by the clonal stem-cell proliferation of red blood cells, white blood cells, and platelets. Increased red blood cell mass results in the hyperviscosity of the blood, an increased risk for thrombosis, poor quality of life, and a shortened life expectancy.
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Results 1 - 10 of 27
Results 1 - 10 of 27