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eChapter 2017: Goodman & Gilman Year in Review New and Noteworthy FDA Approvals

Nelda Murri, PharmD, MBA

PART 1: FIRST-IN-CLASS AGENTS, BREAKTHROUGH THERAPIES, ORPHAN INDICATIONS, COMPANION TESTS, AND NOVEL DEVICES

In 2017 the U.S. Food and Drug Administration (FDA) approved 40 noteworthy new drug products and granted 48 noteworthy new biologic licenses. Among the 40 new drug products are:

  • Seven pharmacological “firsts” (Table P1-1);

  • Twenty-eight new molecular entities that are pharmacologically similar to previously approved drugs (Table P1-2);

  • Three “follow-on” products (see Part 3); and

  • Two previously unapproved marketed drugs (see Part 3).

Table P1-1.New Pharmacological Drug Classes Introduced in 2017
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Table P1-1. New Pharmacological Drug Classes Introduced in 2017
Pharmacological Class First to be Marketed in the U.S. FDA Approved Indication Goodman & Gilman's The Pharmacological Basis of Therapeutics, 13th Edition Reference
Renin-angiotensin-aldosterone system peptide hormone vasoconstrictor Angiotensin II (Giapreza)16 Shock Chapter 30. Renin and Angiotensin
Free radical scavenger17 Edaravone (Radicava)18,19 Amyotrophic lateral sclerosis† Chapter 18. Treatment of Central Nervous System Degenerative Disorders > Edaravone
Isocitrate dehydrogenase 2 enzyme inhibitor20 Enasidenib (Idhifa)22-23 Acute myeloid leukemia with isocitrate dehydrogenase-2 (IDH2) mutation†# Chapter 67. Pathway-Targeted Therapies: Monoclonal Antibodies, Protein Kinase Inhibitors, and Various Small Molecules
Note: The RealTime IDH2 Assay (Abbott Molecular, Inc.), is FDA approved to detect the IDH2 mutation.10,24
Antiviral DNA terminase complex inhibitor Letermovir (Prevymis)25 Cytomegalovirus infection prophylaxis†$ Chapter 62. Antiviral Agents (Nonretroviral)
Multiple kinase inhibitor (FLT3, ITD, TKD, KIT, KIT D816V mutant, PDGFRα/β, VEGFR2, and members of the serine/threonine kinase PKC family) Midostaurin (Rydapt)26,27 FLT3-positive acute myeloid leukemia†$#; mastocytosis†; mast cell leukemia†# Chapter 67. Pathway-Targeted Therapies: Monoclonal Antibodies, Protein Kinase Inhibitors, and Various Small Molecules > Midostaurin
Note: The LeukoStrat CDx FLT3 Mutation Assay (Invivoscribe Technologies Inc.), is approved to detect the FLT3 mutation.10
Rho kinase inhibitor Netarsudil (Rhopressa)28 Glaucoma; ocular hypertension Chapter 69. Ocular Pharmacology
Tryptophan hydroxylase inhibitor Telotristat ethyl (Xermelo)29,30 Carcinoid syndrome diarrhea† Chapter 50. Gastrointestinal Motility and Water Flux, Emesis, and Biliary and Pancreatic Disease > Telotristat ethyl

† Orphan designation

$ Breakthrough therapy designation

# Cancer drug

Table P1-2.New Drugs Licensed in 2017 with Pharmacological Mechanisms Similar to Previously Marketed Entities
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Table P1-2. New Drugs Licensed in 2017 with Pharmacological Mechanisms Similar to Previously Marketed Entities
Generic Name Brand Name Pharmacology FDA-Approved Indication Pharmacologically Similar Agents Goodman & Gilman's The Pharmacological Basis of Therapeutics, 13th Edition Reference
Abaloparatide Tymlos65

Human parathyroid hormone related peptide

[PTHrP(1-34)] analog

 Osteoporosis Teriparatide Chapter 48. Agents Affecting Mineral Ion Homeostasis and Bone Turnover > Drugs Available
Abemaciclib66 Verzenio67 Cyclin-dependent kinase 4 and 6 inhibitor Hormone receptor–positive, human epidermal growth factor receptor 2–negative breast cancer$# Palbociclib$b Chapter 67. Pathway-Targeted ...

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