New Drug and Therapeutic Biologic Approvals in 2015

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1 New Drug and Therapeutic Biologic Approvals in 2015* Product Company Indication/Use Received** Approved Addyi Sprout Pharmaceuticals treatment of premenopausal women 10/27/2009 8/18/2015 flibanserin Raleigh, NC with acquired, generalized hypoactive (NDA) sexual desire disorder (HSSD) For more information: Alecensa Genentech treatment of metastatic anaplastic 7/16/ /11/2015 alectinib South San Francisco, CA lymphoma kinase (ALK)-positive (NDA) (P, A, B) non-small cell lung cancer (NSCLC) in patients who have progressed or are intolerant to treatment with Xalkori For more information: (crizotinib) Aristada Alkermes treatment of schizophrenia 8/22/ /5/2015 aripipraziole lauroxil Waltham, MA (NDA) For more information: Avycaz Allergan treatment of complicated intra- 6/25/2014 2/25/2015 ceftazidime and Parsippany, NJ abdominal infections (ciai) in (NDA) avibactam combination with metronidazole, and complicated urinary tract infections (cuti), including kidney For more information: infections, caused by designated susceptible microorganisms Bridion Merck for the reversal of neuromuscular 10/31/ /15/2015 sugammadex Kenilworth, NJ blockade induced by rocuronium (NDA) bromide and vecuronium bromide in adults undergoing surgery For more information: Cholbam Retrophin treatment of adults and children with 11/21/2013 3/17/2015 cholic acid San Diego, CA bile acid synthesis disorders due to (NDA) single enzyme defects and adjunctive treatment of peroxisomal disorders with liver disease, including Zellweger For more information: spectrum disorders * Approved by the Center for Drug Evaluation and Research (CDER). ** Date application was received by CDER as stated in the -issued Approval Letter. - Standard Review - Priority Review (A) - Accelerated Approval (B) - Breakthrough Therapy 1

2 Corlanor Amgen to reduce hospitalization for 6/27/2014 4/15/2015 ivabradine Thousand Oaks, CA worsening heart failure in persistent (NDA) (chronic) heart failure For more information: Cosentyx Novartis Pharmaceuticals treatment of moderate to severe 10/24/2013 1/21/2015 secukinumab East Hanover, NJ plaque psoriasis in adults who are (BLA) candidates for systemic therapy or phototherapy For more information: Cotellic Genentech treatment of unresectable or 12/11/ /10/2015 cobimetinib South San Francisco, CA metastatic melanoma with either (NDA) the BRAF V600E or V600K gene mutation in combination with Zelboraf (vemurafenib) For more information: Cresemba Astellas Pharma US treatment of invasive aspergillosis 7/8/2014 3/6/2015 isavuconazonium Northbrook, IL and invasive mucormycosis in adults (NDA) sulfate For more information: Daklinza Bristol-Myers Squibb treatment of chronic hepatitis C virus, 3/31/2014 7/24/2015 daclatasvir Princeton, NJ genotype 3 infection in combination (NDA) with Solvadi (sofobuvir) For more information: Darzalex Janssen Biotech treatment of multiple myeloma in 7/9/ /16/2015 daratumumab Horsham, PA patients who have received at least (BLA) (P, A, B) three prior lines of therapy, including a proteasome inhibitor (PI) and an immunomodulatory agent, or who For more information: are double-refractory to a PI or immunomodulatory agent Empliciti Bristol-Myers Squibb treatment of multiple myeloma in 6/29/ /30/2015 elotuzumab Princeton, NJ combination with Revlimid (BLA) (P, B) (lenalidomide) and dexamethasone in patients who have received one to three prior treatments For more information: 2

3 Entresto Novartis Pharmaceuticals treatment of heart failure with 12/17/2014 7/7/2015 sacubitril/valsartan East Hanover, NJ reduced ejection fraction (NDA) For more information: Farydak Novartis Pharmaceuticals treatment of previously treated 3/24/2014 2/23/2015 panobinostat East Hanover, NJ multiple myeloma in adults in (NDA) (P, A) combination with Velcade (bortezomib) and dexamethasone after at least two other types of treatment For more information: have been tried Genvoya Gilead Sciences treatment of HIV-1 infection in adult 11/5/ /5/2015 elvitegravir, cobicistat, Foster City, CA and pediatric patients 12 years and (NDA) entricitabine, tenofovir older alafenamide For more information: Ibrance Pfizer first-line treatment in combination 8/13/2014 2/3/2015 palbociclib New York, NY with letrozole for estrogen receptor- (NDA) (P, A, B) positive, human epidermal growth factor receptor 2-negative (ER+/HER2-) For more information: advanced breast cancer in postmenopausal women Kanuma Alexion Pharmaceuticals enzyme replacement therapy for the 1/8/ /8/2015 sebelipase alfa Cheshire, CT treatment of lysosomal acid lipase (BLA) (P, B) deficiency (LAL-D) (an ultra-rare metabolic disease) For more information: Kengreal The Medicines Company for the reduction of perioperative 12/23/2014 6/22/2015 cangrelor Parsippany, NJ thrombotic events in adults (NDA) undergoing percutaneous coronary intervention (PCI) (Product now marketed by Cheisi USA) Kybella Allergan treatment of moderate to severe 5/13/2014 4/29/2015 deoxycholic acid Parsippany, NJ fat below the chin in adults (NDA) (submental fat) For more information: 3

4 Lenvima Eisai treatment of locally recurrent or 8/14/2014 2/13/2015 lenvatinib Woodcliff Lake, NJ metastatic progressive, radioactive (NDA) iodine-refractory differentiated thyroid cancer For more information: Lonsurf Taiho Oncology treatment of metastatic colorectal 12/19/2014 9/22/2015 trifluridine and tipiracil Princeton, NJ cancer in patients who no longer (NDA) respond to other therapies For more information: Natpara Shire-NPS Pharmaceuticals an adjunct to calcium and vitamin D 10/24/2013 1/23/2015 parathyroid hormone Lexington, MA for the control of hypocalcemia in (BLA) patients with hypoparathyroidism (a rare endocrine disorder) For more information: Ninlaro Takeda Oncology for the treatment of multiple myeloma 7/10/ /20/2015 ixazomib Cambridge, MA in combination with Revlimid (NDA) (lenalidomide) and dexamethasone in patients who have received at least one prior treatment For more information: Nucala GlaxoSmithKline add-on maintenance treatment of 11/4/ /4/2015 mepolizumab Research Triangle Park, NC severe asthma in patients 12 years (BLA) and older with the eosinophilic phenotype For more information: Odomzo Novartis Pharmaceuticals treatment of locally advanced basal 9/26/2014 7/24/2015 sonidegib East Hanover, NJ cell carcinoma that has recurred (NDA) following surgery or radiation, or in patients who are not candidates for For more information: surgery or radiation Orkambi Vertex Pharmaceuticals treatment of cystic fibrosis in patients 11/5/2014 7/2/2015 lumacaftor/ivacaftor Boston, MA with two copies of the F508del gene (NDA) (P, B) mutation For more information: 4

5 Portrazza Eli Lilly treatment in combination with 12/2/ /24/2015 necitumumab Indianapolis, IN gemcitabine and cisplatin for advanced (BLA) metastatic squamous NSCLC For more information: Praluent Regeneron Pharmaceuticals treatment of adults with heterozygous 11/24/2014 7/24/2015 alirocumab Tarrytown, NY familial hypercholesterolemia or (BLA) Sanofi US clinical atherosclerotic cardiovascular Bridgewater, NJ disease, such as heart attacks or strokes, who require additional For more information: lowering of LDL cholesterol (LDL-C) Praxbind Boehringer-Ingelheim reversal of the blood thinning effects 2/19/ /16/2015 idarucizumab Pharmaceuticals of Pradaxa (dabigatran etexilate) for (BLA) (P, A, B) Ridgefield, CT use in emergency surgery/urgent procedures or in life-threatening or For more information: uncontrolled bleeding Repatha Amgen treatment of adults with heterozygous 8/27/2014 8/27/2015 evolocumab Thousand Oaks, CA familial hypercholesterolemia or (BLA) clinical atherosclerotic cardiovascular disease who require additional For more information: lowering of LDL-C and treatment of patients with homozygous familial hypercholesterolemia who require additional lowering of LDL-C Rexulti Lundbeck treatment of schizophrenia in adults 7/11/2014 7/10/2015 brexpiprazole Deerfield, IL and as add-on treatment to anti- (NDA) Otsuka America depressant therapy in adults with Pharmaceutical major depressive disorder Rockville, MD For more information: Savaysa Daiichi Sankyo reduction of stroke and systemic 1/8/2014 1/8/2015 edoxaban Parsippany, NJ embolism in non-valvular atrial (NDA) fibrillation and treatment of deep vein thrombosis (DVT) and pulmonary For more information: embolism (PE) Strensiq Alexion Pharmaceuticals treatment of perinatal-, infantile- 12/23/ /23/2015 asfotase alfa Cheshire, CT and juvenile-onset hypophasphatasia (BLA) (P, B) (an ultra-rare metabolic disease) For more information: 5

6 Tagrisso AstraZeneca treatment of NSCLC in patients with 6/5/ /13/2015 osimertinib Wilmington, DE epidermal growth factor receptor (NDA) (P, A, B) (EGFR) T790M gene mutation and whose disease has gotten worse after treatment with other EGFR-blocking For more information: therapy Tresiba Novo Nordisk for use alone, or in combination, for 9/29/2011 9/25/2015 insulin degludec Plainsboro, NJ glycemic control in adults with (NDA) type 1 and type 2 diabetes For more information: Unituxin United Therapeutics first-line treatment of high-risk 4/11/2014 3/10/2015 dinutuximab Silver Spring, MD pediatric neuroblastoma (BLA) For more information: Uptravi Actelion Pharmaceuticals treatment of pulmonary arterial 12/22/ /21/2015 selexipag South San Francisco, CA hypertension (PAH) in adults (NDA) For more information: Varubi Tesaro prevention of delayed chemotherapy- 9/5/2014 9/1/2015 rolapitant Waltham, MA induced nausea and vomiting (CINV) (NDA) in adults For more information: Veltassa Relypsa treatment of hyperkalemia (a condition 10/21/ /21/2015 patiromer Redwood City, CA when potassium levels are too high in (NDA) the blood) For more information: Viberzi Allergan treatment of irritable bowel syndrome 6/27/2014 5/27/2015 eluxadoline Parsippany, NJ with diarrhea (IBS-D) in adults (NDA) Furiex Pharmaceuticals Morrisville, NC For more information: 6

7 Vraylar Allergan treatment of schizophrenia and manic 11/19/2012 9/17/2015 cariprazine Parsippany, NJ or mixed episodes of bipolar I disorder (NDA) in adults For more information: Xuriden Wellstat Therapeutics treatment of hereditary orotic aciduria 1/8/2015 9/4/2015 uridine triacetate Gaithersburg, MD (a rare metabolic disorder) (NDA) For more information: Yondelis Janssen Products treatment of unresectable or 11/24/ /23/2015 trabectedin Horsham, PA metastatic liposarcoma and (NDA) leiomyosarcoma (two types of soft tissue sarcoma) For more information: Zurampic Ardeo Biosciences treatment of hyperuricemia (high levels 12/29/ /22/2015 lesinurad San Diego, CA of uric acid in the blood) associated (NDA) AstraZeneca with gout in combination with a Wilmington, DE xanthine oxidase inhibitor For more information: New Biologic Approvals in 2015* BLA Product Company Indication/Use Received** Approved Adynovate Baxalta (Shire) treatment of hemophilia A (congenital 11/25/ /13/2015 antihemophilic factor Bannokburn, IL factor VIII deficiency) in patients 12 (BLA) (recombinant), years and older for on-demand PEGylated treatment and control of bleeding episodes and routine prevention to reduce the frequency of bleeding For more information: episodes Anavip Instituto Bioclon management of North American 3/18/2013 5/6/2015 Crotalidae immune Toriello Guerra, Mexico rattlesnake envenomation in adult (BLA) F(ab')2 (equine) Rare Disease Therapeutics and pediatric patients Franklin, TN For more information: * Approved by the Center for Biologics Evaluation and Research (CBER). ** Date application was received by CBER as stated in the Statistical Review. - Standard Review - Priority Review 7

8 New Biologic Approvals in 2015 BLA Anthrasil Emergent BioSolutions treatment of inhalation anthrax 7/25/2014 3/24/2015 anthrax immune Gaithersburg, MD in adult and pediatric patients in (BLA) globulin intravenous combination with appropriate (human) antibacterial medicines For more information: Bexsero GlaxoSmithKline active immunization against invasive 7/24/2024 1/23/2015 meningococcal Research Triangle Park, NC meningococcal disease caused by (BLA) group B vaccine Neisseria meningitidis serogroup B in people 10 through 25 years of age For more information: Coagadex Bio Product Laboratory replacement therapy for hereditary 7/11/ /20/2015 coagulation factor X Durham, NC factor X deficiency in patients 12 years (BLA) (human) and older for on-demand treatment and control of bleeding episodes and perioperative management of For more information: bleeding in patients with mild hereditary factor X deficiency Fluad Seqirus active immunization of adults 65 years 11/25/ /24/2015 influenza vaccine, Holly Springs, NC and older against influenza disease (BLA) adjuvanted caused by influenza virus subtypes A and B For more information: Imlygic Amgen local treatment of unresectable 7/28/ /27/2015 talimogene Thousand Oaks, CA cutaneous, subcutaneous and nodal (BLA) laherparepvec lesions in patients with melanoma recurrence after initial surgery For more information: Ixinity Emergent BioSolutions treatment of hemophilia B for control 4/6/2012 4/29/2015 coagulation factor IX Gaithersburg, MD and prevention of bleeding episodes (BLA) (recombinant) and perioperative management in adults and children age 12 years and older For more information: (Product now marketed by Aptevo Therapeutics) 8

9 New Biologic Approvals in 2015 BLA Nuwiq Octapharma USA treatment of hemophilia A in adults 6/5/2014 9/4/2015 simoctocag alfa Hoboken, NJ and children for on-demand treatment (BLA) and control of bleeding episodes, management of bleeding and routine For more information: prevention to reduce frequency of bleeding episodes Quadracel Sanofi Pasteur active immunization against 3/24/2014 3/24/2015 diphtheria and tetanus Swiftwater, PA diphtheria, tetanus, pertussis and (BLA) toxoids and acellular poliomyelitis in children 4 through pertussis adsorbed 6 years of age and inactivated poliovirus vaccine For more information: Raplixa The Medicines Company adjunct to hemostasis for mild to 1/31/2014 4/30/2015 fibrin sealant (human) Parsippany, NJ moderate bleeding in adults undergoing (BLA) surgery when control of bleeding by standard techniques (such as suture, ligature and cautery) is ineffective or impractical For more information: (Product is now owned by Mallinckrodt) Vonvendi Baxalta (Shire) for on-demand treatment and 12/19/ /8/2015 von Wilibrand factor Bannockburn, IL control of bleeding episodes in (BLA) (recombinant) adults with von Willebrand disease For more information: The content of this survey has been obtained through government and industry sources. The information may not be comprehensive. For more specific information about a particular product, contact the individual company directly. Definitions Accelerated Approval A program of the, which allows early approval of a drug for serious ort life-threatening illness that offers a benefit over current approved treatments. bases its approval on a "surrogate endpoint" (e.g. a laboratory measure) or other clinical measure that is considered reasonably likely to predict clinical benefit. The medicine mist undergo additional testing after approval to confirm the benefit. BLA (Biologic License Application) Application submitted by a sponsor to the for approval of a new biologic for sale and marketing in the United States. 9

10 Breakthrough Therapy Upon request by a sponsor, the can grant this designation to expedite the development and review of a drug or biologic intended, along or in combination with one or more other drugs, to treat a serious or life threatening disease or condition and preliminary clinical evidence indicates that it may demonstrate substantial improvement over existing therapies on one or more clinicallysignificant endpoints, such as substantial treatment effects observed early in clinical development. If a drug or biologic is designated as a breakthrough therapy, the will expedite the development and review. With this designation, all Fast Track features convey to the medicine. NDA (New Drug Application) Application submitted by a sponsor to the for approval of a new pharmaceutical for sale and marketing in the United States. Orphan Designation Upon request by a sponsor, the can grant special status ( orphan designation ) to a drug or biologic to treat a rar disease or condition. In order to receive an orphan designation, a qualifying drug or biologic must be intended for the treatment, diagnosis, or prevention of a rare disease or condition that usually affects fewer than 200,000 people in the United States. 10

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