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Specialty Pipeline Update

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Specialty Pipeline Update Specialty Pipeline Update D Drug Insights > June 2016 → New drug information → New indications ® ™ ● Epclusa (sofosbuvir/velpatasvir): The Food and Drug ● Glassia (alpha1 proteinase inhibitor [human]): Shire Administration (FDA) approved Gilead’s Epclusa for all and Kamada’s Glassia received FDA approval for self- forms of hepatitis C virus (genotypes 1 thru 6). Epclusa administration. Glassia is indicated to treat is a once-daily, fixed-dose combination tablet containing alpha1-antitrypsin deficiency in people who have sofosbuvir (approved in 2013 as Sovaldi®), and symptoms of emphysema at home. velpatasvir, a new antiviral drug. ● Zinbryta™ (daclizumab): The FDA approved Biogen and AbbVie’s Zinbryta for the treatment of adults with relapsing forms of multiple sclerosis (MS). Zinbryta is a long-acting, self-administered monthly injection. ● Ocaliva™ (obeticholic acid): The FDA approved Intercept’s Ocaliva tablets for the treatment of primary biliary cholangitis (PBC), formerly primary biliary cirrhosis, in combination with ursodeoxycholic acid (UDCA) in adults with an inadequate response to UDCA, or as monotherapy in adults unable to tolerate UDCA. Currently, Ocaliva is being studied in non-alcoholic steatohepatitis, which may result in off-label use. ● Afstyla® (recombinant factor VIII single chain): CSL Behring’s Afstyla is a new hemophilia A drug indicated in adults and children for on-demand treatment, prophylaxis and perioperative management of bleeding episodes. While the information in this newsletter is from sources we believe to be reliable, we do not warrant that the information in this document is free from error. Use it only as a guide. Statements regarding drugs or manufacturers are not intended as promotion; those statements should not be used to make assumptions about formulary status. Each trademarked drug name is the property of its respective owner. Specialty Pipeline > June 2016 Page 2 → June news ● “The multi-year saga of eteplirsen, a Duchenne ● “Roche’s Ocrevus™ (ocrelizumab) won FDA priority review, the Swiss drugmaker said, meaning it could muscular dystrophy drug from Cambridge, MA-based hit the U.S. market by year’s end, slightly ahead of Sarepta Therapeutics, will continue to drag on. previous ‘early 2017’ expectations. If approved, Sarepta said that the FDA won’t complete its review of Ocrevus is expected to be a formidable competitor, its drug, eteplirsen, by the established May 26 given its data in the primary progressive form of the deadline. As a result, rather than approve or reject disease. No other MS drug has yet proven to be eteplirsen—which has the chance to be the first effective in those hard-to-treat patients. Ocrevus is marketed drug ever for Duchenne — the FDA will also up for approval in the more common form, simply continue its review for an undetermined period relapsing remitting MS.” 1 of time. Sarepta said that the FDA will ‘strive to complete their work in as timely a manner as possible,’ though no specific timeline was provided.” 2 Specialty Pipeline > June 2016 Page 3 Specialty new product approvals in the past twelve months Route of Generic name Brand name Manufacturer Indication(s) administration Date approved* sofosbuvir/velpatasvir Epclusa® Gilead Hepatitis C (all genotypes) Oral June 2016 daclizumab high-yield process Zinbryta™ Biogen and AbbVie Multiple sclerosis Subcutaneous May 2016 injection obeticholic acid Ocaliva™ Intercept Primary biliary cholangitis Oral May 2016 recombinant factor VIII single Afstyla® CSL Behring Hemophilia A Intravenous May 2016 chain infusion infliximab Remsima™ Celltrion/Pfizer Biosimilar to Remicade® Intravenous April 2016 infusion emtricitabine/tenofovir Descovy® Gilead HIV Oral April 2016 alafenamide defibrotide Defitelio® Jazz Hepatic veno-occlusive Intravenous March 2016 disease following a infusion hematopoietic stem cell transplant reslizumab Cinqair™ Teva Severe eosinophilic asthma Intravenous March 2016 infusion ixekizumab Taltz® Lilly Psoriasis Subcutaneous March 2016 injection emtricitabine/tenofovir Odefsey® Gilead HIV Oral March 2016 alafenamide/rilpivirine coagulation Factor IX Idelvion® CSL Behring Hemophilia B Intravenous March 2016 infusion octocog alfa Kovaltry™ Bayer Hemophilia A Intravenous March 2016 infusion tofacitinib Xeljanz® XR Pfizer Rheumatoid arthritis Oral February 2016 grazoprevir/elbasvir Zepatier™ Merck Hepatitis C (genotypes 1 Oral January 2016 and 4) selexipag Uptravi™ Actelion Pulmonary arterial Oral December 2015 hypertension von Willebrand factor, Vonvendi™ Baxalta von Willebrand disease Intravenous December 2015 recombinant infusion sebelipase alfa Kanuma™ Alexion/Synageva Enzyme replacement therapy Intravenous December 2015 infusion asfotase alfa Strensiq™ Alexion Enzyme replacement therapy Subcutaneous November 2015 injection Factor VIII, recombinant, Adynovate™ Baxalta Hemophilia A Intravenous November 2015 pegylated infusion mepolizumab Nucala™ GlaxoSmithKline Severe eosinophilic asthma Subcutaneous November 2015 injection elvitegravir/cobicistat/ Genvoya™ Gilead HIV Oral November 2015 emtricitabine/tenofovir alafenamide Factor X concentrate Coagadex™ BioProducts Laboratory Factor X deficiency Intravenous October 2015 infusion uridine triacetate Xuriden™ Wellstat Therapeutics Hereditary orotic aciduria Oral October 2015 Factor VIII, recombinant Nuwiq® Octapharma Hemophilia A Intravenous September 2015 infusion continued Specialty Pipeline > June 2016 Page 4 Specialty new product approvals in the past twelve months (continued) Route of Generic name Brand name Manufacturer Indication(s) administration Date approved* dichlorphenamide Keveyis™ Taro Primary hyperkalemic and Oral August 2015 hypokalemic periodic paralysis evolocumab Repatha™ Amgen High cholesterol Subcutaneous August 2015 injection daclatasvir Daklinza™ BMS Hepatitis C (genotype 3) Oral July 2015 ombitasvir, paritaprevir, Technivie™ AbbVie Hepatitis C (genotype 4) Oral July 2015 ritonavir with ribavirin alirocumab Praluent™ Sanofi-Genzyme High cholesterol Subcutaneous July 2015 injection lumacaftor/ivacaftor Orkambi™ Vertex Cystic fibrosis Oral July 2015 New indications for approved specialty products Generic name Brand name Manufacturer New indication Date approved* alpha1 proteinase Glassia Shire and Kamada Self-administration indication (alpha1- June 2016 inhibitor [human] antitrypsin deficiency in people who have symptoms of emphysema) ledipasvir/sofosbuvir Harvoni® Gilead For the treatment of liver transplant recipients February 2016 with genotype 1 or 4 infection without cirrhosis, or with compensated cirrhosis, and for genotype 1-infected patients with decompensated cirrhosis daclatasvir Daklinza™ Bristol-Myers Squibb For use in combination with Sovaldi® February 2016 (sofosbuvir) for the treatment of chronic hepatitis C virus (HCV) in patients co-infected with HIV and for HCV patients with advanced cirrhosis, including decompensated cirrhosis and patients with post-liver transplant recurrence of HCV genotype 1 infection onabotulinumtoxinA Botox® Allergan For the treatment of adults with lower limb January 2016 spasticity secukinumab Cosentyx® Novartis For the treatment of adult patients with active January 2016 ankylosing spondylitis and active psoriatic arthritis ledipasvir/sofosbuvir Harvoni® Gilead For use in patients with genotype 4, 5 and November 2015 6 chronic hepatitis C virus infection and in patients co-infected with HIV ambrisentan Letairis® Gilead For use in combination with tadalafil for the October 2015 treatment of pulmonary arterial hypertension adalimumab Humira® AbbVie For the treatment of moderate to severe September 2015 hidradenitis suppurativa cysteamine Procysbi® Raptor Pharmaceuticals Pediatric nephropathic cystinosis in patients August 2015 ages 2–6 years old abobotulinumtoxinA Dysport® Ipsen Treatment of upper limb spasticity in adults July 2015 Specialty Pipeline > June 2016 Page 5 Oncology product approvals in the past twelve months Route of Generic name Brand name Manufacturer Indication(s) administration Date approved* atezolizumab Tecentriq™ Roche Metastatic urothelial bladder Intravenous May 2016 cancer infusion cabozantinib Cabometyx® Exelixis Advanced renal cell carcinoma Oral April 2016 venetoclax Venclexta™ AbbVie/Genentech Chronic lymphocytic leukemia Oral April 2016 captisol-enabled Evomela™ Spectrum For use as a high-dose conditioning Intravenous March 2016 melphalan treatment prior to hematopoietic infusion stem cell transplantation in patients with multiple myeloma (MM) and for the palliative treatment of patients with MM for whom oral therapy is not appropriate alectinib Alecensa® Genentech Non-small cell lung cancer Oral December 2015 elotuzumab Empliciti™ Bristol-Myers Squibb/ Multiple myeloma Intravenous December 2015 AbbVie infusion bendamustine Bendeka™ Teva Chronic lymphocytic leukemia Intravenous December 2015 and indolent B-cell non-Hodgkin infusion lymphoma necitumumab Portrazza™ Lilly Non-small cell lung cancer Intravenous November 2015 infusion ixazomib Ninlaro® Millennium Multiple myeloma Oral November 2015 Pharmaceuticals/ Takeda daratumumab Darzalex™ Janssen Multiple myeloma Intravenous November 2015 infusion osimertinib Tagrisso™ AstraZeneca Non-small cell lung cancer Oral November 2015 irinotecan liposome Onivyde™ Merrimack Pancreatic cancer Intravenous November 2015 injection Pharmaceuticals infusion trabectedin Yondelis® Janssen Soft tissue sarcoma Intravenous November 2015 infusion cobimetinib Cotellic™ Genentech Metastatic melanoma Oral November 2015 talimogene
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