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eChapter 68: The Goodman & Gilman Year in Review: 2014 New and Noteworthy FDA Approvals

Nelda Murri, PharmD, MBA, Chief of Pharmacy, Jonathan M. Wainwright Memorial VA Medical Center, Clinical Assistant Professor, University of Washington School of Pharmacy

PART 1: FIRST-IN-CLASS AGENTS

The FDA approved 54 new drugs and biologics of note in 2014. Thirty-four new drugs are pharmacologically similar to others already marketed (see Part 2 of this chapter). The remaining 20 represent first-in-class agents indicated for the management of cancers, cardiovascular risk, hepatitis C virus (HCV) infection, insomnia, inflammatory bowel disease, leishmaniasis, lipodystrophy, mucopolysaccharidosis, onychomycosis, and pulmonary fibrosis, and for immunization against serogroup B meningococcal disease (eTable 68–1).

eTable 68–1New Pharmacological Drug Classes Introduced in 2014
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eTable 68–1 New Pharmacological Drug Classes Introduced in 2014
PHARMACOLOGICAL CLASS FIRST TO BE ­MARKETED IN THE U.S. FDA-APPROVED INDICATION GOODMAN & GILMAN’S THE PHARMACOLOGICAL BASIS OF THERAPEUTICS, 12TH ED. REFERENCE
Aminoacyl-transfer ribonucleic acid (tRNA) synthetase (AARS) inhibitor Tavaborole (kerydin) Onychomycosis of the toenails

Chapter 57. Antifungal Agents

Chapter 65. Dermatological Pharmacology > Onychomycosis
Anaplastic lymphoma kinase (ALK) tyrosine kinase inhibitor Ceritinib$† (zykadia) Non–small cell lung cancer (NSCLC) Chapter 36. Pulmonary Pharmacology
Anti–programmed death receptor 1 (PD-1) blocker Nivolumab$† (opdivo) Melanoma

Chapter 60. General Principles of Cancer Chemotherapy

Chapter 62. Targeted Therapies: Tyrosine Kinase Inhibitors, Monoclonal Antibodies, and Cytokines; see also

Update: Programmed Cell Death-1 (PD-1) Pathway Checkpoint Inhibition: Immuno-oncology for Advanced Melanoma
Pembrolizumab$† (keytruda)
Bispecific (CD3/CD19) T cell–engaging (BiTE) monoclonal antibody Blinatumomab$† (blincyto) Philadelphia chromosome-negative precursor B-cell acute lymphoblastic leukemia (B-ALL)

Chapter 35. Immunosuppressants, Tolerogens, and Immunostimulants > Antigens

Chapter 60. General Principles of Cancer Chemotherapy

Chapter 62. Targeted Therapies: Tyrosine Kinase Inhibitors, Monoclonal Antibodies, and Cytokines; see also eUpdate 62-2, Blinatumomab: A CD19-/CD3-Bispecific T-cell Engaging (BiTE) Antibody for B-cell Leukemia Immunotherapy—A First-in-Class Agent that Directs T Cells to Tumor Cell Targets18
α4β7 integrin antagonist Vedolizumab (entyvio) Ulcerative colitis; Crohn’s disease Chapter 47. Pharmacotherapy of Inflammatory Bowel Disease > Pathogenesis of Inflammatory Bowel Disease
Interleukin-6 (IL-6) inhibitor Siltuximab† (sylvant) Multicentric Castleman’s disease Chapter 62. Targeted Therapies: Tyrosine Kinase Inhibitors, Monoclonal Antibodies, and Cytokines > Mechanisms of Action
Leptin receptor (ObR) agonist Metreleptin† (myalept) Generalized lipodystrophy Chapter 1. Drug Invention and the Pharmaceutical Industry > Has the Target Been Validated?
Meningococcal group B vaccine Meningococcal group B vaccine$ (trumenba) Prevention of invasive meningococcal disease caused by N. meningitidis serogroup B Chapter 35. Immunosuppressants, Tolerogens, and Immunostimulants > Vaccines
Multiple kinase inhibitor Nintedanib$† (ofev) Idiopathic pulmonary fibrosis Chapter 61. Cytotoxic Agents > Clinical Toxicities
Unknown Pirfenidone*$† (esbriet)
N-acetylgalactosamine-6-sulfatase, recombinant Elosulfase alfa† (vimizim) Mucopolysaccharidosis type IVA (Morquio A syndrome) (See Mucopolysaccharidoses in Harrison’s Principles of Internal Medicine, 18th ed.)
NS5A protein inhibitor (ledipasvir) in combination with a nucleotide analog NS5B polymerase inhibitor (sofosbuvir) Ledipasvir in combination with sofosbuvir$ (harvoni) Hepatitis C virus genotype 1 infection Chapter 58....

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