RxOutlook® 1st Quarter 2019 OptumRx brand pipeline forecast Route of Regulatory Estimated Specialty Orphan Drug name Generic name Company Drug class Therapeutic use administration status release date drug drug 2019 Possible launch date Ophthalmological DS-300 DS-300 Eton undisclosed SC Filed NDA 2019 unknown N disease anti-sclerostin Evenity romosozumab Amgen Osteoporosis SC Filed NDA 2/2019 Y N monoclonal antibody tetrahydrofolate iclaprim iclaprim Motif Bio Bacterial infections IV Filed NDA 2/13/2019 Y Y dehydrogenase inhibitor tazarotene/ IDP-118 Valeant retinoid/ corticosteroid Psoriasis TOP Filed NDA 2/15/2019 N N halobetasol adenosine deaminase Mavenclad cladribine Merck/ Teva resistant Multiple sclerosis PO Filed NDA 2/15/2019 Y N deoxyadenosine analog Lotemax Gel loteprednol Valeant corticosteroid Ocular inflammation OP Filed NDA 2/25/2019 N N Nex Gen etabonate turoctocog alfa glyco-PEGylated factor NN-7088 Novo Nordisk Hemophilia IV/SC Filed BLA 2/27/2019 Y N pegol VIII derivative selective sphingosine-1 BAF-312 siponimod Novartis phosphate receptor Multiple sclerosis PO Filed NDA 3/1/2019 Y N agonist midazolam midazolam UCB benzodiazepine Seizures Intranasal Filed NDA 3/1/2019 N Y (USL-261) XeriSol glucagon Xeris glucagon analog Diabetes mellitus SC Filed NDA 3/1/2019 N N Glucagon optum.com/optumrx 1 RxOutlook® 1st Quarter 2019 Route of Regulatory Estimated Specialty Orphan Drug name Generic name Company Drug class Therapeutic use administration status release date drug drug dopamine receptor JZP-507 sodium oxybate Jazz Narcolepsy PO Filed NDA 3/1/2019 Y N agonist NMDA receptor Major depressive esketamine esketamine Janssen Intranasal Filed NDA 3/8/2019 N N antagonist disorder (MDD) prostaglandin agonist/ latanoprost/ rho kinase- Glaucoma/ Ocular Roclatan Aerie OP Filed NDA 3/14/2019 N N netarsudil mesylate norepinephrine transport hypertension protein inhibitor HER2/neu receptor Herceptin trastuzumab Halozyme Breast cancer SC Filed BLA 3/15/2019 Y N antagonist gamma aminobutyric allopregnanolone acid-A (GABA-A) Postpartum SAGE-547 SAGE/ Ligand IV Filed NDA 3/19/2019 Y Y (brexanolone) receptor allosteric depression/ Seizures modulator Jazz Narcolepsy/ Sleep ADX-N05 solriamfetol Pharmaceuticals/ phenylalanine derivative PO Filed NDA 3/20/2019 N Y apnea Aerial BioPharma mometasone corticosteroid/ GSP-301 furoate/ Glenmark Allergic rhinitis NA Filed NDA 3/21/2019 N N antihistamine olopatadine HCl sodium-dependent glucose transporter 1 Zynquista sotagliflozin Sanofi/ Lexicon Diabetes mellitus PO Filed NDA 3/22/2019 N N (SGLT-1) and SGLT-2 inhibitor fosphenytoin fosphenytoin sodium/ sodium/ sulfobutylether sulfobutylether Sedor anticonvulsant Seizures IM/IV Filed NDA 3/22/2019 Y N beta- beta-cyclodextrin cyclodextrin sodium sodium nonsteroidal anti- Recro Pharma/ N-1539 meloxicam inflammatory drug Pain IV Filed NDA 3/24/2019 Y N Alkermes (NSAID) optum.com/optumrx 2 RxOutlook® 1st Quarter 2019 Route of Regulatory Estimated Specialty Orphan Drug name Generic name Company Drug class Therapeutic use administration status release date drug drug NRL-1 diazepam Neurelis benzodiazepine Seizures Intranasal Filed NDA 3/25/2019 N Y long-acting muscarinic acetylcholine receptor Chronic obstructive aclidinium/ AstraZeneca/ (mAChR) Duaklir Pressair pulmonary disease INH Filed NDA 3/31/2019 N N formoterol Actavis/ Circassia antagonist/long-acting (COPD) beta 2 agonist (LAMA/LABA) AMG-504-1 glucagon Eli Lilly/ Locemia glucagon analog Diabetes mellitus Intranasal Filed NDA 2Q2019 N N Rizaport IntelGenx / Red Hill rizatriptan triptans Acute migraines PO Filed NDA 4/1/2019 N N (VersaFilm) Biopharma EVK-001 metoclopramide Evoke Pharma antidopiminergics Diabetic gastroparesis Intranasal Filed NDA 4/1/2019 N Y Primary immunodeficiency/ RI-002 RI-002 ADMA Biologics immunoglobulin Respiratory syncytial IV Filed BLA 4/2/2019 Y N virus (RSV)/ Bacterial infections Multiple myeloma/ Sarcoma/ Diffuse large Karyopharm selective inhibitor of B-cell lymphoma KPT-330 selinexor PO Filed NDA 4/6/2019 Y Y Therapeutics nuclear export (SINE) (DLBCL)/ Acute myeloid leukemia (AML) calcitonin gene-related Aimovig (140 Filed erenumab-aooe Amgen peptide (CGRP) Migraine headaches SC 4/15/2019 N N mg dose) sNDA receptor antagonist Human dolutegravir/ GlaxoSmithKline/ Tivicay/ Epivir integrase inhibitor/ NRTI immunodeficiency virus PO Filed NDA 4/18/2019 Y N lamivudine Shionogi (HIV) Psoriasis/ Crohn's BI-655066 Boehringer interleukin-23 (IL-23) risankizumab disease/ Ankylosing IV/SC Filed BLA 4/25/2019 Y Y (ABBV-066) Ingelheim/ AbbVie inhibitor spondylitis/ Asthma optum.com/optumrx 3 RxOutlook® 1st Quarter 2019 Route of Regulatory Estimated Specialty Orphan Drug name Generic name Company Drug class Therapeutic use administration status release date drug drug Nabriva Contepo fosfomycin cell wall inhibitor Bacterial infections IV Filed NDA 4/30/2019 Y N Therapeutics anesthetic/ Nonsteroidal bupivacaine/ HTX-011 Heron Therapeutics Anti-inflammatory Drug Pain Instillation Filed NDA 4/30/2019 N N meloxicam (NSAID) Dengue fever Dengvaxia Sanofi Pasteur vaccine Dengue fever SC Filed BLA 5/1/2019 N N vaccine onasemnogene Spinal muscular Zolgensma Novartis/ Regenxbio gene therapy IV Filed BLA 5/1/2019 Y Y abeparvovec atrophy (SMA) dopamine receptor APD-421 amisulpride Acacia Nausea/ Vomiting IV Filed NDA 5/5/2019 N N antagonist FLT-3 receptor tyrosine Acute myeloid quizartinib quizartinib Daiichi Sankyo PO Filed NDA 5/25/2019 Y Y kinase inhibitor leukemia (AML) Slinda drospirenone Exeltis progesterone Pregnancy prevention PO Filed NDA 5/27/2019 N N NKTR-181 NKTR-181 Nektar opioid agonist Pain PO Filed NDA 5/28/2019 N N Imvamune; Imvamune; MVA- Bavarian Nordic vaccine Smallpox SC Filed BLA 6/1/2019 Y N MVA-BN BN osmotic gradient Bronchitol mannitol Pharmaxis enhancer; mucus Asthma/ Cystic fibrosis INH Filed NDA 6/20/2019 N Y clearance enhancer melanocortin type 4 Female sexual disorder PT-141 bremelanotide Palatin/ AMAG SC Filed NDA 6/23/2019 Y N receptor agonist (FSD) alpha-2/beta-1 vascular Ehlers-Danlos Edsivo celiprolol HCl Acer Therapeutics PO Filed NDA 6/25/2019 Y Y adrenergic agent Syndrome (vEDS) Thiola tiopronin Retrophin reducing agent Cystinuria PO Filed NDA 6/30/2019 N N human Ryplazim ProMetic/ Hematech plasminogen Plasminogen deficiency IV Filed BLA Mid-2019 Y Y plasminogen tadalafil phosphodiesterase-5 tadalafil VersaFilm IntelGenx Erectile dysfunction PO Filed NDA Mid-2019 Y N VersaFilm (PDE-5) inhibitor optum.com/optumrx 4 RxOutlook® 1st Quarter 2019 Route of Regulatory Estimated Specialty Orphan Drug name Generic name Company Drug class Therapeutic use administration status release date drug drug sphingosine 1- phosphate 1 (S1PR1) Multiple sclerosis/ RPC-1063 ozanimod Celgene PO CRL 3Q2019 Y N and 5 (S1PR5) receptor Ulcerative colitis (UC) modulator TRV-130 oliceridine Trevena opioid receptor agonist Pain IV CRL 3Q2019 N N astodrimer sodium VivaGel Starpharma viral attachment inhibitor Bacterial infections VG CRL 2H2019 N N (SPL-7013) Zalviso sufentanil, ARX-01 AcelRx opioid analgesic Pain SL CRL 2H2019 Y N Breast cancer/ Pancreatic cancer/ Pancreatic cancer/ Small cell lung cancer sacituzumab Immunomedics/ RS7-SN-38 antibody- IMMU-132 (SCLC)/ Non-small cell IV CRL 2H2019 Y Y govitecan Royalty Pharma drug conjugate lung cancer (NSCLC)/ Colorectal cancer/ Esophageal cancer/ Urinary bladder cancer Intracerebral/ FastTrk/ VTS-270 kleptose Sucampo/ INDPA sugar molecule Niemann-Pick disease 2H2019 Y Y Intrathecal Breakthru phosphoinositide 3- Breast cancer/ Head BYL-719 alpelisib Novartis kinase CA (PIK3CA) PO InTrial 2H2019 Y N and neck cancer inhibitor MNK-812 oxycodone Mallinckrodt opioid agonist Pain PO CRL 2H2019 N N Clostridium difficile Filed Vancocin vancomycin HCl ANI antibacterial infection (CDI)/ PO 7/1/2019 N N sNDA Enterocolitis optum.com/optumrx 5 RxOutlook® 1st Quarter 2019 Route of Regulatory Estimated Specialty Orphan Drug name Generic name Company Drug class Therapeutic use administration status release date drug drug Amyloid tafamidis cardiomyopathy/ amyloid accumulation Vyndaqel meglumine Pfizer Familial amyloid PO Filed NDA 7/1/2019 Y Y inhibitor polyneuropathy (FAP)/ Cardiomyopathy Erythropoietic protoporphyria (EPP)/ melanocortin receptor 1 Scenesse afamelanotide Clinuvel Polymorphous light SC Filed NDA 7/8/2019 Y Y (MC-1) agonist eruption (PLE/PMLE)/ Vitiligo Amyotrophic lateral Portage/ Biohaven/ glutamate release sclerosis (ALS)/ SL/ BHV-0223 riluzole Filed NDA 7/15/2019 N Y Catalent inhibitor Migraines/ Social Transmucosal anxiety disorder beta-lactamase inhibitor/ relebactam/ carbapenem/ MK-7655 imipenem/ Merck Bacterial infections IV Filed NDA 7/16/2019 Y N dehydropeptidase-1 cilastatin inhibitor Shield Therapeutics/ Anemia/ Irritable bowel Feraccru ferric trimaltol AOP Orphan iron replacement PO Filed NDA 7/23/2019 N N syndrome (IBS) Pharma Non-small cell lung cancer (NSCLC)/ FastTrk/ entrectinib entrectinib Ignyta tyrosine kinase inhibitor Colorectal cancer/ PO 8/1/2019 N Y Breakthru Solid tumors/ Neuroblastoma Tenosynovial giant cell selective macrophage PLX108-01 tumor (TGCT)/ pexidartinib Daiichi Sankyo colony stimulating factor PO Filed NDA 8/3/2019 N Y (PLX-3397) Pigmented Villonodular 1 receptor inhibitor Synovitis (PVNS) Dravet syndrome/ serotonin receptor Fintepla fenfluramine Zogenix Lennox-Gastaut PO Filed NDA 8/6/2019 Y Y agonist syndrome (LGS) optum.com/optumrx 6 RxOutlook® 1st Quarter 2019 Route of Regulatory Estimated Specialty Orphan Drug name Generic name Company Drug class Therapeutic use administration status