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PART 2: OTHER NOTEWORTHY (NONBIOLOGIC) APPROVALS AND REGULATORY ACTIONS

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In 2016 the U.S. Food and Drug Administration (FDA) approved 22 new small-molecule drugs and granted 32 noteworthy biologic licenses. Among the 22 small molecules are:

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  • Six pharmacological "firsts" (see Part 1);

  • Three diagnostic imaging agents for use with PET imaging (see Part 1);

  • Three previously unapproved marketed drugs (ephedrine [Akovaz] injection,1 tetracaine ophthalmic solution,2 and methylene blue (Provayblue) injection (an orphan drug);3

  • Two entities previously regulated only as dietary supplements (prasterone [dehydroepiandrosterone [DHEA]4 and vitamin B2 [riboflavin]5; see Table 6); and

  • Eight new molecular entities that are pharmacologically similar to previously approved drugs (see Table 5):

    1. Brivaracetam (Briviact):6 the second synaptic vesicle protein (SV2A) ligand to be marketed in the United States, it is an analogue of levetiracetam;

    2. Crisaborole (Eucrisa):7 the third FDA-approved phosphodiesterase 4 (PDE-4) inhibitor;

    3. Elbasvir and grazoprevir (Zepatier):8 was granted breakthrough therapy status for the treatment of chronic HCV genotype 1 infection in patients with end-stage renal disease on hemodialysis and for the treatment of chronic HCV genotype 4 infection9

      • Elbasvir is the third HCV NS5A protein inhibitor to win FDA approval (it is only marketed in a fixed-dose combination with grazoprevir under the brand name, Zepatier);8

      • Grazoprevir is the fifth HCV NS3/4A protease inhibitor to win FDA approval (it too is only marketed in a fixed-dose combination with elbasvir under the brand name, Zepatier);8

    4. Lixisenatide (Adlyxin);10 lixisenatide and insulin glargine (Soliqua 100/33):11 lixisenatide is the fifth glucagon-like peptide-1 (GLP-1) receptor agonist to be marketed in the United States and the second GLP-1 receptor agonist to be marketed in a fixed-dose combination with a long-acting insulin (each 3-mL prefilled pen device contains 100 units/mL of insulin glargine and 33 mcg/mL of lixisenatide);11

    5. Obeticholic acid (Ocaliva):12 The fourth bile acid agent to marketed in the United States;

    6. Rucaparib (Rubraca):13 the second poly (ADP-ribose) polymerase (PARP) inhibitor to reach the U.S. market, it was designated by FDA as a breakthrough drug and approved in conjunction with the FoundationFocus CDxBRCA assay14 to detect the gene alterations in BRCA1 and BRCA2 necessary for patients to qualify to receive this new treatment15 (see Part 1); and

    7. Velpatasvir and sofosbuvir (Epclusa):16 Velpatasvir is the third HCV NS5A protein inhibitor to win FDA approval, it is marketed only in a fixed-dose combination with sofosbuvir, making it the second NS5A protein inhibitor/sofosbuvir combination to enter the U.S. market, but also the first for the treatment of all six genotypes of HCV.17

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Part 1 looked back at first-in-class drug approvals; other breakthrough therapies and orphan indications; important new diagnostic tests; and novel medical devices. The noteworthy biologics approved in 2016 are described in Part 3. Throughout the series, orphan, breakthrough, and cancer therapy designations are notated by the symbols †, $, and #, respectively, and biologics are notated by ...

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