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PART 1: FIRST-IN-CLASS DRUGS, PHARMACOLOGICAL SIMILARS, BREAKTHROUGH THERAPIES, ORPHAN INDICATIONS, CANCER APPROVALS, AND COMPANION DIAGNOSTIC TESTS

Note: The following symbols are used throughout.

orphan indications

$ breakthrough therapies

# cancer therapies

biologic license designations

First-In-Class and Pharmacological Similars

In 2018, the U.S. Food and Drug Administration (FDA) granted 46 noteworthy new drug application (NDA) licenses and approved 29 noteworthy new biologic license applications (BLAs). Among the 46 NDA approvals are:

  • Nine pharmacological “firsts,” including two RNA-based gene silencing therapies (inotersen [an antisense oligonucleotide] and patisiran$ [a small interfering ribonucleic acid (siRNA) sequence])1 and a “tissue-agnostic” cancer drug, larotrectinib$# (Table P1-1);2

  • Three ablative agents: dehydrated (99%) alcohol (Ablysinol)3 used to induce controlled cardiac septal infarct in adults with hypertrophic obstructive cardiomyopathy;4 iobenguane I 131$# (Azedra)5, a radioablative for pheochromocytoma or paraganglioma; 6,7 and lutetium Lu 177 dotatate# (Lutathera),8 a radiolabeled somatostatin analog for somatostatin receptor–positive gastroenteropancreatic neuroendocrine tumors;9-11

  • Thirty-three new molecular entities that are pharmacologically similar to previously approved drugs (Table P1-2); and

  • Primatene Mist,12 a chlorofluorocarbon (CFC)-free inhaled epinephrine reformulation for the self-management of mild asthma, reintroduced after a 7-year absence from the market and representing the only OTC metered-dose inhaler available in the United States.13,14

Table P1-1.New Pharmacological Drug Classes Introduced in 2018

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