Meds Entry Watch
New Medicines Approved in 2017

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The following table provides supplementary information on the manufacturer and approved indication(s) for each medicine that received first-time market authorization by the US Food and Drug Administration (FDA), the European Medicines Agency (EMA), and/or Health Canada in 2017.

Indications for new medicines approved by the FDA, the EMA, and/or Health Canada in 2017
Medicine (trade name)* Approved indications Manufacturer
Abaloparatide (Tymlos) Indicated for the treatment of postmenopausal women with osteoporosis at high risk for fracture2 Radius Health
Abemaciclib (Verzenio) A kinase inhibitor indicated:

  • in combination with fulvestrant for the treatment of women with hormone receptor (HR)-positive, human epidermal growth factor receptor 2 (HER2)-negative advanced or metastatic breast cancer with disease progression following endocrine therapy
  • as monotherapy for the treatment of adult patients with HRpositive, HER2-negative advanced or metastatic breast cancer with disease progression following endocrine therapy and prior chemotherapy in the metastatic setting2
Eli Lilly
Acalabrutinib (Calquence)C,O Indicated for the treatment of adult patients with mantle cell lymphoma (MCL) who have received at least one prior therapy2 AstraZeneca
Angiotensin II (Giapreza) A vasoconstrictor to increase blood pressure in adults with septic or other distributive shock2 La Jolla Pharmaceutical Company
Avelumab (Bavencio)B,C,O Indicated for the treatment of:

  • Metastatic Merkel cell carcinoma (MCC) in previously treated adults
  • Patients with locally advanced or metastatic urothelial carcinoma (UC) who have disease progression during or following platinum-based chemotherapy or within 12 months of neoadjuvant or adjuvant treatment with platinum-based chemotherapy1
EMD Serono
Axicabtagene ciloleucel (Yescarta)B,C,O,G Indicated for the treatment of adult patients with relapsed or refractory large B-cell lymphoma after two or more lines of systemic therapy, including diffuse large B-cell lymphoma (DLBCL) not otherwise specified, primary mediastinal large B-cell lymphoma, high grade B-cell lymphoma, and DLBCL arising from follicular lymphoma2 Kite Pharma
Baricitinib (Olumiant)O Indicated for reducing the signs and symptoms of moderate to severe rheumatoid arthritis (RA) in adult patients who have responded inadequately to one or more disease-modifying anti-rheumatic drugs (DMARDs)1 Eli Lilly
Benralizumab (Fasenra)B Indicated as an add-on maintenance treatment of adult patients with severe eosinophilic asthma1 AstraZeneca
Benznidazole (Benznidazole)O Indicated in pediatric patients 2 to 12 years of age for the treatment of Chagas disease (American trypanosomiasis), caused by Trypanosoma cruzi2 Chemo Research
Betrixaban (Bevyxxa) Indicated for the prophylaxis of venous thromboembolism (VTE) in adult patients hospitalized for an acute medical illness who are at risk for thromboembolic complications due to moderate or severe restricted mobility and other risk factors for VTE2 Portola Pharmaceuticals
Brigatinib (Alunbrig)C,O Indicated as a monotherapy for the treatment of adult patients with anaplastic lymphoma kinase (ALK)-positive metastatic non-small cell lung cancer (NSCLC) who have progressed on or who were intolerant to an ALK inhibitor (crizotinib)1 Ariad Pharmaceuticals, Inc.
Brodalumab (Siliq)B Indicated for the treatment of moderate to severe plaque psoriasis in adult patients who are candidates for systemic therapy or phototherapy1 Valeant Pharmaceuticals
Cenegermin (Oxervate)B,O Treatment of moderate (persistent epithelial defect) or severe (corneal ulcer) neurotrophic keratitis in adults3 Dompe Farmaceutici S.p.A.
Cerliponase alfa (Brineura)B,O Indicated to slow the loss of ambulation in symptomatic pediatric patients 3 years of age and older with late infantile neuronal ceroid lipofuscinosis type 2 (CLN2), also known as tripeptidyl peptidase 1 (TPP1) deficiency2 BioMarin Pharmaceutical Inc.
Coagulation Factor IX [recombinant], glycoPEGylated (Rebinyn)B Indicated in adults and children with hemophilia B (congenital factor IX deficiency or Christmas disease) for: control and prevention of bleeding episodes; control and prevention of bleeding in the perioperative setting
Also indicated in patients 18 years and above with hemophilia B for routine prophylaxis to prevent or reduce the frequency of bleeding episodes1
Novo Nordisk
Copanlisib (Aliqopa)C,O Indicated for the treatment of adult patients with relapsed follicular lymphoma (FL) who have received at least two prior systemic therapies2 Bayer Healthcare
Delafloxacin (Baxdela) A fluoroquinolone antibacterial indicated in adults for the treatment of acute bacterial skin and skin structure infections (ABSSSI) caused by designated susceptible bacteria2 Melinta Therapeutics
Deutetrabenazine (Austedo)O Indicated for the treatment of: chorea associated with Huntington’s disease; tardive dyskinesia in adults2 Teva
Dupilumab (Dupixent)B Indicated for the treatment of adult patients with moderate-to-severe atopic dermatitis whose disease is not adequately controlled with topical prescription therapies or when those therapies are not advisable1 Sanofi-Aventis
Durvalumab (Imfinzi)B,C Indicated for the treatment of patients with:

  • Locally advanced or metastatic urothelial carcinoma who: have disease progression during or following platinum-containing chemotherapy; have disease progression within 12 months of neoadjuvant or adjuvant treatment with platinum-containing chemotherapy
  • Locally advanced, unresectable non-small cell lung cancer (NSCLC) whose disease has not progressed following platinum-based chemoradiation therapy1
AstraZeneca
Edaravone (Radicava)O Indicated for the treatment of amyotrophic lateral sclerosis (ALS)2 Mitsubishi Tanabe
Emicizumab (Hemlibra)B,O Indicated for hemophilia A (congenital factor VIII deficiency) patients with factor VIII inhibitors as routine prophylaxis to prevent bleeding or reduce the frequency of bleeding episodes1 Genetech, Inc.
Enasidenib (Idhifa)C,O Indicated for the treatment of adult patients with relapsed or refractory acute myeloid leukemia (AML) with an isocitrate dehydrogenase-2 (IDH2) mutation as detected by an FDA-approved test2 Celgene
Ertugliflozin (Steglatro) Indicated for use as an adjunct to diet and exercise to improve glycemic control in adult patients with type 2 diabetes mellitus for whom metformin is inappropriate due to contraindications or intolerance
Also indicated in adult patients with type 2 diabetes mellitus to improve glycemic control in combination with: metformin, metformin and sitagliptin when the therapy listed above, along with diet and exercise, does not provide adequate glycemic control1
Merck
Glecaprevir, pibrentasvir (Maviret) Indicated for the treatment of adult patients with chronic hepatitis C virus (HCV) genotype 1, 2, 3, 4, 5, or 6 infection with or without compensated cirrhosis. This includes patients with HCV genotype 1 infection who were previously treated with either a regimen of NS5A inhibitor or with a NS3/4A protease inhibitor but not both classes of inhibitors1 AbbVie
Guselkumab (Tremfya)B Indicated for the treatment of adult patients with moderate-to-severe plaque psoriasis who are candidates for systemic therapy or phototherapy1 Janssen Pharma
Inotuzumab ozogamicin (Besponsa)B,C,O Indicated as a monotherapy for the treatment of adults with relapsed or refractory CD22-positive B-cell precursor acute lymphoblastic leukemia (ALL)1 Pfizer
Latanoprostene bunod (Vyzulta) Indicated for the reduction of intraocular pressure in patients with open-angle glaucoma or ocular hypertension2 Valeant Pharmaceuticals
Letermovir (Prevymis)O Indicated for the prophylaxis of cytomegalovirus (CMV) infection in adult CMV-seropositive recipients [R+] of an allogeneic hematopoietic stem cell transplant (HSCT)1 Merck & Co.
Macimorelin (Macrilen)O Indicated for the diagnosis of adult growth hormone deficiency2 Strongbridge BioPharma
Midostaurin (Rydapt)C,O Indicated in combination with standard cytarabine and daunorubicin induction and cytarabine consolidation chemotherapy for the treatment of adult patients with newly diagnosed FLT3-mutated acute myeloid leukemia (AML)1 Novartis Pharma
Naldemedine (Symproic) Indicated for the treatment of opioid-induced constipation (OIC) in adult patients with chronic non-cancer pain2 Purdue Pharma
Neratinib (Nerlynx)C Indicated for the extended adjuvant treatment of adult patients with early stage HER2-overexpressed/amplified breast cancer, to follow adjuvant trastuzumab-based therapy2 Puma Biotechnology
Netarsudil (Rhopressa) Indicated for the reduction of elevated intraocular pressure in patients with open-angle glaucoma or ocular hypertension2 Aerie Pharmaceuticals, Inc.
Niraparib (Zejula)C,O Indicated for the maintenance treatment of adult patients with recurrent epithelial ovarian, fallopian tube, or primary peritoneal cancer who are in a complete or partial response to platinum-based chemotherapy2 Tesaro, Inc.
Ocrelizumab (Ocrevus)B Indicated for the treatment of adult patients with relapsing remitting multiple sclerosis (RRMS) with active disease defined by clinical and imaging features; and for the management of adult patients with early primary progressive multiple sclerosis (PPMS) as defined by disease duration and level of disability, in conjunction with imaging features characteristic of inflammatory activity1 Roche
Ozenoxacin (Ozanex) Indicated for the topical treatment of impetigo in patients aged 2 months and older1 Ferrer internacional S.A.
Padeliporfin di-potassium (Tookad)C Indicated as monotherapy for adult patients with previously untreated, unilateral, low-risk, adenocarcinoma of the prostate with a life expectancy ≥ 10 years and:

  • clinical stage T1c or T2a
  • Gleason Score ≤ 6, based on high-resolution biopsy strategies
  • PSA ≤ 10 ng/mL
  • 3 positive cancer cores with a maximum cancer core length of 5 mm in any one core or 1-2 positive cancer cores with ≥ 50 % cancer involvement in any one core or a PSA density ≥ 0.15 ng/mL/cm3 3
Steba Biotech S.A.
Plecanatide (Trulance) Indicated in adults for treatment of chronic idiopathic constipation (CIC)2 Synergy Pharm
Ribociclib (Kisqali)C indicated in combination with letrozole for the treatment of postmenopausal women with hormone receptor (HR)-positive, human epidermal growth factor receptor 2 (HER2)-negative advanced or metastatic breast cancer as an initial endocrine-based therapy1 Novartis
Sarilumab (Kevzara)B Indicated in the treatment of adult patients with moderately to severely active rheumatoid arthritis (RA) who have had an inadequate response or intolerance to one or more biologic or non-biologic disease-modifying anti-rheumatic drugs (DMARDs)1 Sanofi-Aventis
Semaglutide (Ozempic) Indicated for the once-weekly treatment of adult patients with type 2 diabetes mellitus to improve glycemic control, in combination with:

  • diet and exercise in patients for whom metformin is inappropriate due to contraindication or intolerance
  • metformin, when diet and exercise plus maximal tolerated dose of metformin do not achieve adequate glycemic control
  • metformin and a sulfonylurea, when diet and exercise plus dual therapy with metformin and a sulfonylurea do not achieve adequate glycemic control
  • basal insulin with metformin, when diet and exercise plus basal insulin with metformin do not achieve adequate glycemic control1
Novo Nordisk
Telotristat etiprate (Xermelo)C,O Indicated for the treatment of carcinoid syndrome diarrhea in combination with somatostatin analog (SSA) therapy in adults inadequately controlled by SSA therapy2 Lexicon Pharma
Tisagenlecleucel (Kymriah)B,C,O,G Indicated for the treatment of:

  • Patients up to 25 years of age with B-cell precursor acute lymphoblastic leukemia (ALL) that is refractory or in second or later relapse
  • Adult patients with relapsed or refractory (r/r) large B-cell lymphoma after two or more lines of systemic therapy including diffuse large B-cell lymphoma (DLBCL) not otherwise specified, high grade B-cell lymphoma and DLBCL arising from follicular lymphoma2
Novartis Pharma
Tivozanib (Fotivda)C Indicated for the first line treatment of adult patients with advanced renal cell carcinoma (RCC) and for adult patients who are VEGFR and mTOR pathway inhibitor-naïve following disease progression after one prior treatment with cytokine therapy for advanced RCC3 EUSA Pharma (UK) Ltd
Vaborbactam (Vabomere) Indicated for the treatment of patients 18 years and older with complicated urinary tract infections (cUTI) including pyelonephritis caused by designated susceptible bacteria2 The Medicines Company
Valbenazine (Ingrezza)O Indicated for the treatment of adults with tardive dyskinesia2 Neurocrin Biosciences
Herpes zoster vaccine [recombinant, adjuvanted] (Shingrix Vaccine)B Indicated for prevention of herpes zoster (HZ, or shingles) in adults 50 years of age or older1 GlaxoSmithKline
Vestronidase alfa (Mepsevii)B,O Indicated in pediatric and adult patients for the treatment of mucopolysaccharidosis VII (MPS VII, Sly syndrome)2 Ultragenyx
Voretigene neparvovec (Luxturna)B,O,G Indicated for the treatment of patients with confirmed biallelic RPE65 mutation-associated retinal dystrophy2 Spark Therapeutics, Inc.
Voxilaprevir (Vosevi) Indicated for the treatment of chronic hepatitis C virus (HCV) infection in adult patients, without cirrhosis or with compensated cirrhosis, who have:

  • genotype 1, 2, 3, 4, 5, or 6 infection and have previously been treated with an HCV regimen containing an NS5A inhibitor;
  • genotype 1, 2, 3, or 4 infection and have been previously treated with an HCV regimen containing sofosbuvir without an NS5A inhibitor1
Gilead Sciences

Indications from: 1 Health Canada (HC); 2 US Food and Drug Administration (FDA); 3 European Medicines Agency (EMA).

* B: biologic; C: cancer; O: orphan medicines; G: gene therapies.
Data source: US Food and Drug Administration Novel Drugs 2017; European Medicines Agency Human Medicines Highlights 2017; Health Canada databases.

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