Baricitinib: First Global Approval
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DOI: 10.1007/s40265-017-0723-3
Abstract: Baricitinib (Olumiant™) is an orally-administered, small-molecule, janus-associated kinase (JAK) inhibitor developed by Eli Lilly and Incyte Corporation for the treatment of rheumatoid arthritis (RA), atopic dermatitis and systemic lupus erythematosus. JAKs transduce intracellular signals from… read more here.
Keywords: baricitinib; baricitinib first; treatment; global approval ... See more keywords
Sarilumab: First Global Approval
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DOI: 10.1007/s40265-017-0724-2
Abstract: Sarilumab (Kevzara™) is a fully human IgG1 monoclonal antibody that binds specifically to both soluble and membrane-bound interleukin (IL)-6 receptors (sIL-6Rα and mIL-6Rα) and thereby inhibits IL-6-mediated signalling through these receptors. Subcutaneous sarilumab is approved… read more here.
Keywords: global approval; sarilumab; first global; rheumatoid arthritis ... See more keywords
Abaloparatide: First Global Approval
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DOI: 10.1007/s40265-017-0780-7
Abstract: Abaloparatide (Tymlos™) is a synthetic peptide analogue of human parathyroid hormone-related protein that was developed by Radius Health as an osteoanabolic agent for the treatment of postmenopausal osteoporosis. Abaloparatide acts through selective activation of the… read more here.
Keywords: abaloparatide first; global approval; treatment postmenopausal; first global ... See more keywords
Bictegravir: First Global Approval
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DOI: 10.1007/s40265-018-0896-4
Abstract: Gilead Sciences has developed a single tablet anti-HIV-1 medication (Biktarvy®) combining the novel integrase strand transfer inhibitor (INSTI) bictegravir with the nucleos(t)ide reverse transcriptase inhibitors (NRTIs) emtricitabine and tenofovir alafenamide. This fixed dose combination has… read more here.
Keywords: bictegravir; bictegravir first; global approval; approval bictegravir ... See more keywords
Tafenoquine: First Global Approval
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DOI: 10.1007/s40265-018-0979-2
Abstract: Tafenoquine (Krintafel™, Arakoda™), an orally-active 8-aminoquinoline anti-malarial drug, is a long-acting analogue of primaquine with activity against pre-erythrocytic (liver) and erythrocytic (asexual) forms as well as gametocytes of Plasmodium species that include Plasmodium vivax (P.… read more here.
Keywords: vivax malaria; global approval; vivax; tafenoquine ... See more keywords
Patisiran: First Global Approval
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DOI: 10.1007/s40265-018-0983-6
Abstract: Patisiran (ONPATTRO™) is a double-stranded small interfering RNA encapsulated in a lipid nanoparticle for delivery to hepatocytes. By specifically binding to a genetically conserved sequence in the 3′ untranslated region of mutant and wild-type transthyretin… read more here.
Keywords: patisiran; ttr; global approval; patisiran first ... See more keywords
Tagraxofusp: First Global Approval
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DOI: 10.1007/s40265-019-01087-z
Abstract: Tagraxofusp (tagraxofusp-erzs) [Elzonris™] is an intravenously administered CD123-directed cytotoxin (composed of human interleukin-3 and a truncated diphtheria toxin payload) that was developed by Stemline Therapeutics, Inc. for the treatment of blastic plasmacytoid dendritic cell neoplasm… read more here.
Keywords: treatment; tagraxofusp first; tagraxofusp; global approval ... See more keywords
Solriamfetol: First Global Approval
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DOI: 10.1007/s40265-019-01123-y
Abstract: Solriamfetol (Sunosi™) is an orally active, selective dopamine and norepinephrine reuptake inhibitor that was recently approved in the USA as a treatment for excessive daytime sleepiness (hypersomnia) associated with narcolepsy and obstructive sleep apnoea (OSA).… read more here.
Keywords: solriamfetol first; global approval; sleepiness; solriamfetol ... See more keywords
Alpelisib: First Global Approval
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DOI: 10.1007/s40265-019-01161-6
Abstract: Alpelisib (Piqray™)—an orally available phosphatidylinositol 3-kinase (PI3K) inhibitor with specific activity against PI3K alpha (PI3Kα)—is being developed by Novartis for the treatment of breast cancer. Alpelisib has demonstrated efficacy in combination with fulvestrant as treatment… read more here.
Keywords: alpelisib first; pi3k; global approval; first global ... See more keywords
Volanesorsen: First Global Approval
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DOI: 10.1007/s40265-019-01168-z
Abstract: Volanesorsen (Waylivra®), an antisense oligonucleotide inhibitor of apolipoprotein CIII (apoCIII) mRNA, is being developed by Ionis Pharmaceuticals through its subsidiary company, Akcea Therapeutics, to treat familial chylomicronemia syndrome (FCS), hypertriglyceridemia and familial partial lipodystrophy (FPL).… read more here.
Keywords: volanesorsen first; global approval; volanesorsen; first global ... See more keywords
Sarecycline: First Global Approval
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DOI: 10.1007/s40265-019-1053-4
Abstract: Sarecycline (Seysara™) is an oral, once-daily, tetracycline-class drug for which a tablet formulation is approved in the USA for the treatment of inflammatory lesions of non-nodular moderate to severe acne vulgaris in patients aged ≥ 9 years. The… read more here.
Keywords: dermatology; sarecycline; global approval; sarecycline first ... See more keywords