Drug Pipeline Monthly Update

Transcription

1 Drug Pipeline Monthly Update Critical updates in an ever changing environment December 2017 New drug information Juluca (dolutegravir/rilpivirine): Viiv Healthcare received U.S. Food and Drug Administration (FDA) approval for Juluca for the treatment of certain adults with human immunodeficiency virus type 1 (HIV-1). Juluca is a fixed-dose tablet that is the first complete treatment regimen containing only two drugs to treat HIV-1 in contrast to three or more drugs included in the standard HIV treatment regimens. Juluca can be used in adults with HIV-1 infections whose virus: Whose virus is currently suppressed on a stable regimen for at least 6 months, With no history of treatment failure Who have no known substitutions associated with resistance to the individual components of Juluca (Tivicay and Edurant ). Sublocade (buprenorophine): Indivior announced FDA approval for Sublocade, a once-monthly medication treatment option for moderate-to-severe opioid use disorder in adult patients who have initiated treatment with a transmucosal buprenorphine-containing product and have been on a stable dose for a minimum of seven days. It is injected subcutaneously by a health care professional and should be used as a part of a complete treatment program that includes counseling and psychosocial support. Ozempic (semaglutide): Novo Nordisk announced FDA approval for their once weekly glucagon-like peptide 1 (GLP-1) agonist Ozempic as an adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes. Novo Nordisk will price the drug at $676 per prescription, which they described as at parity to current market-leading drugs in the same class. 1 Novo Nordisk expects Ozempic will be available in January Lonhala Magnair (glycopyrrolate): The FDA approved Lonhala Magnair, a twice daily inhalation solution for the long-term, maintenance treatment of airflow obstruction in people with chronic obstructive pulmonary disease (COPD), including chronic bronchitis and/or emphysema. Sunovion expects to launch in early Admelog (insulin lispro injection): The FDA granted full approval for Sanofi s Admelog, a shortacting insulin indicated to improve control in blood sugar levels in adults and pediatric patients aged three years and older with type 1 or 2 diabetes. Admelog, submitted through the 505 (b) (2) pathway, is a follow-on product to Eli Lilly s Humalog. The FDA granted tentative approval in September 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.

2 Drug Pipeline Monthly Update: December 2017 Page 2 Vyzulta (latanoprostene bunod) ophthalmic solution: The FDA approved Valeant International s Vyzulta for the once daily treatment of reduction of intraocular pressure (IOP) in patients with open-angle glaucoma or ocular hypertension. Vyzulta contains a prostaglandin analog that breaks down to latanoprost acid which increases aqueous humor outflow through the uveoscleral pathway and butanediol mononitrate which releases nitric oxide to increase outflow through the trabecular meshwork and Schlemm s canal. 3 Rhopressa (netarsudil) ophthalmic solution: Aerie received FDA approval for Rhopressa, a once daily treatment to reduce elevated IOP in patients with open-angle glaucoma or ocular hypertension. Rhopressa is the first Rho kinase inhibitor approved by the FDA. TriVisc (sodium hyaluronate): The FDA approved Orthogenrx s medical device TriVisc for the treatment of pain in osteoarthritis of the knee in patients who have failed to respond adequately to conservative non-pharmacologic therapy and simple analgesics (e.g., acetaminophen). TriVisc is administered by intra-articular injection by a health care professional. It is administered in three doses, one week apart. TriVisc functions as a physical lubricant inside the knee joint.4 Sinuva (mometasone furoate): Intersect ENT, Inc received FDA approval for their steroid-releasing sinus implant Sinuva for the treatment of recurrent nasal polyp disease in patients who have had previous ethmoid sinus surgery. Sinuva is placed in-office and releases mometasone furoate to the site of polyp disease for 90 days. The implant can be removed at day 90 or earlier using standard surgical instruments. Generic drug information Fluoxetine (fluoxetine 60 mg): Par launched their generic for Almatica s Fluoxetine 60 mg tablets for the treatment of major depressive disorder, obsessive compulsive disorder, bulimia nervosa and panic disorder. Novacort gel (Paramox HC: pramoxine/hydrocortisone): Apotex launched their generic version of Novum Pharma s Novacort gel, 1 2% for the relief of inflammatory and pruritic manifestations of corticosteroid-responsive dermatoses. Istalol (timolol maleate ophthalmic solution 0.5%): Apotex launched their generic version of Valeant s Istalol ophthalmic solution for the treatment of elevated IOP in patients with ocular hypertension or open-angle glaucoma. Apotex has 180-day exclusivity; two other manufacturers may launch their generic versions of Istalol on May 28, Viagra (sildenafil citrate): Teva has launched their generic version of Pfizer s Viagra for the treatment of erectile dysfunction. Teva has 180-day exclusivity. Multiple manufacturers are set to launch their generic versions of Viagra on June 9, According to IMS data, Viagra had $1.4 billion in annual U.S. sales as of August Viread (tenofovir disoproxil fumarate) 300 mg: Teva launched the first generic for Gilead Science s Viread 300 mg tablet. Multiple manufacturers will launch their generic versions of Viread on January 26, In addition, two manufacturers are set to launch their generic version of Viread 150 mg, 200 mg, and 300 mg tablets on January 26, Viread, all strengths, had annual U.S. sales of $762 million according to IMS data as of October 2017.

3 Drug Pipeline Monthly Update: December 2017 Page 3 New molecular entity approvals in the past twelve months netarsudil Rhopressa Aerie Glaucoma or ocular hypertension December 2017 semaglutide Ozempic Novo Nordisk Diabetes December 2017 letermovir Prevymis Merck Prophylaxis of CMV infection and disease November 2017 secnidazole Solosec Symbiomix Bacterial vaginosis October 2017 benznidazole Benznidazole Tablets Chemo Research/ DNDi/Mundo Sano Chagas disease August 2017 pitavastatin Nikita Lupin High cholesterol August 2017 betrixaban Bevyxxa Lupin Prophylaxis of venous thromboembolism July 2017 delafloxacin Baxdela Melinta Skin infections June 2017 naldemedine Symproic Shionogi Pain March 2017 safinamide Xadago Newron Parkinson s disease March 2017 desmopressin nasal spray Noctiva Allergan and Serenity Nocturnal polyuria March 2017 house dust mite sublingual allergy immunotherapy Odactra Merck, Sharp & Dohme House dust mite allergies March 2017 plecanatide Trulance Synergy Chronic idiopathic constipation January 2017 *Date indicates FDA approval date only. The product launch and marketing dates are determined by the approved product s manufacturer. Other new product approvals in the past twelve months mometasone furoate Sinuva Intersect ENT, Inc Recurrent nasal polyps December 2017 glycopyrrolate Lonhala Magnair Sunovion COPD December 2017 buprenorphine injection Sublocade Indivior Opioid use disorder December 2017 norethindrone/ethinyl estradiol/ ferrous fumarate Taytulla Allergan Pregnancy prevention October 2016 dolutegravir/rilpivirine Juluca Viiv Healthcare HIV-1 infection December 2017 sodium hyaluronate TriVisc OrthogenRx, Inc Osteoarthritis November 2017 aprepitant Cinvanti Heron Therapeutics Chemotherapy-induced nausea and vomiting aripiprazole with sensor Abilify MyCite Otsuka Drug-device combo for schizophrenia, bipolar disorder and major depression latanoprostene bunod Vyzulta Valeant November 2017 November 2017 Glaucoma or ocular hypertension November 2017 pregabalin extended release Lyrica CR Pfizer Neuropathic pain October 2017 rolapitant Varubi Tesara/Opko Health Chemotherapy-induced nausea and vomiting October 2017 continued

4 Drug Pipeline Monthly Update: December 2017 Page 4 Other new product approvals in the past 12 months (continued) exenatide extended-release Bydureon BCise AstraZeneca Diabetes October 2017 insulin aspart FIAsp Novo Nordisk Diabetes October 2017 fluticasone propionate nasal spray fluticasone furoate, umeclidinium, vilanterol amphetamine extended release suspension Xhance Optinose US, Inc Nasal Polyps October 2017 Trelegy Ellipta GSK/Innoviva COPD September 2017 Adzenys ER Neos Therapeutics ADHD September 2017 spironolactone suspension CaroSpir CMP Pharma Cardiovascular August 2017 insulin lispro Admelog Sanofi Diabetes September 2017 (full approval December 2017) lesinurad/allopurinol Duzallo Ironwood Uncontrolled gout August 2017 pitavastatin sodium Nikita Lupin High cholesterol August 2017 beclomethasone dipropionate Qvar RediHaler Teva Asthma August 2017 insulin glargine Lusduna Nexvue Merck Diabetes August 2017 methylphenidate extended-release orally disintegrating tablets mixed salts of a single-entity amphetamine products Cotempla XR-ODT Neos Therapeutics ADHD July 2017 Mydayis Shire ADHD July 2017 pitavastatin Zypitamag Zydus High cholesterol July 2017 epinephrine injection Symjepi Adamis Corporation Allergic reactions June 2017 cetirizine ophthalmic solution Zerviate Nicox Ophthalmic Eye itching May 2017 methotrexate solution Xatmep Silvergate oxycodone, immediate release RoxyBond Inspirion/Daiichi Sankyo ALL and arthritis in pediatric patients April 2017 Pain, abuse deterrent April 2017 dapagliflozin/saxagliptin Qtern AstraZeneca Diabetes February 2016 lisdexamfetamine Vyvanse Shire ADHD February 2017 naloxone nasal spray, 2 mg Narcan Adapt Pharma Inc Opioid overdose January 2017 fluticasone propionate fluticasone propionate/ salmeterol ArmonAir Teva Asthma January 2017 RespiClick AirDuo Teva Asthma January 2017 RespiClick oxymetazoline Rhofade Allergan Rosacea January 2017 hydrocodone extended release Vantrela ER Teva Pain, abuse deterrent January 2017 morphine extended release Arymo ER Egalet Pain, abuse deterrent January 2017 *Date indicates FDA approval date only. The product launch and marketing dates are determined by the approved product s manufacturer.

5 Drug Pipeline Monthly Update: December 2017 Page 5 Pipeline watch Generic Name Brand Name Manufacturer Indication(s) Anticipated FDA Decision Date ertugliflozin N/A Merck/Pfizer Diabetes December 2017 ertugliflozin/metformin N/A Merck/Pfizer Diabetes December 2017 ertugliflozin/sitagliptin N/A Merck/Pfizer Diabetes December 2017 acetaminophen/ibuprofen Maxigesic AFT Pain December 2017 ethinyl estradiol/levonorgestrel transdermal Twirla Agile Therapeutics Pregnancy prevention December 2017 testosterone undecanoate Jatenzo Clarus Therapeutics Testosterone replacement December 2017 CAM2038, buprenorphine N/A Braeburn FluidCrystal Opioid use disorder January 2018 ciprofloxacin Linhaliq Aradigm and Grifols Non-cystic fibrosis bronchiectasis patients with chronic lung infections with Pseudomonas aeruginosa polyethylene glycol and ascorbate January 2018 Plenvu Salix and Norgine Bowel cleansing February 2018 andexanet alfa AndexXa Portola Anticoagulant reversal agent February 2018 bictegravir/emtricitabine/ tenofovir alafenamide N/A Gilead HIV-1 infection February 2018 benzhydrocodone/acetaminophin Apadaz KemPharm Pain, abuse deterrent February 2018 lidocaine patch 1.8% ZTLido Sorrento Therapeutics netarsudil Rhopressa Aerie Postherpetic neuralgia February 2018 Glaucoma or ocular hypertension February 2018 alprostadil Vitaros Apricus/Allergan Erectile dysfunction March 2018 elagolix N/A Abbvie Inc./ Neurocrine Biosciences Pain associated with endometriosis April 2018 testosterone undecanoate Tlando Lipocine Testosterone replacement May 2018 botulinum toxin type A Evosyal Evolus/Daewoong Frown lines May 2018 KIT-302 (celecoxib/amlodipine) N/A Kitov Pharma Osteoarthritis pain/hypertension May 2018 plazomicin N/A Achaogen Bacterial infection June 2018 ulipristal acetate Esmya Allergan Abnormal bleeding with uterine fibroids June 2018 IDP-118 (halobetasol propionate/ tazarotene) aripiprazole lauroxil NanoCrystal Dispersion N/A Ortho Dermatologic/ Valeant Plaque psoriasis June 2018 N/A Alkermes Schizophrenia, bipolar disorder and major depression June 2018

6 Drug Pipeline Monthly Update: December 2017 Page 6 First generic approvals of top selling brand name drugs in the past twelve months tenofovir disoproxil fumarate, 300 mg Viread 300 mg Teva HIV December 2017 sildenafil citrate Viagra Pfizer Erectile dysfunction December 2017 glatiramer acetate Copaxone Teva Neuroscienc Multiple sclerosis October 2017 prasugrel Effient Eli Lilly/ Daiichi Sankyo Reduction of CV events August 2017 eletriptan Relpax Pfizer Migraine August 2017 mesalamine delayed release Lialda Zydus Ulcerative colitis August 2017 moxifloxacin ophthalmic solution Vigamox Apotex Eye infection July 2017 testosterone topical transdermal solution Axiron Lilly Testosterone replacement July 2017 atomoxetine Strattera Eli Lilly ADHD June 2017 ezetimibe/simvastatin Vytorin Merck/Schering- Plough High cholesterol May 2017 desvenlafaxine SR Pristiq Pfizer Depression March 2017 methylphenidate ER Concerta Janssen ADHD January 2017 * Date usually indicates FDA approval date. The product s launch date is determined by the manufacturer. Generic approvals that do not come to market within three months of approval are listed and dated when they enter the market. Other first generic launches in the past twelve months timolol maleate ophth solution Istalol Valeant Glaucoma December 2017 pramoxine/hydrocortisone Novacort gel 1 2% Novum Pharma Skin irritation December 2017 fluoxetine tab, 60 mg Fluoxetine Almatica Major depressive disorder, obsessive compulsive disorder, bulimia nervosa, panic disorder November 2017 dapsone gel, 5% Aczone Allergan Acne November 2017 oseltamivir suspension Tamiflu Genentech Influenza November 2017 carvedilol ER Coreg CR GSK Cardiovascular November 2017 testosterone gel Testim 1% Endo Testosterone replacement October 2017 abacavir solution Ziagen Viiv Healthcare HIV October 2017 sodium phenylbutyrate Buphenyl Horizon Pharma Urea cycle disorders October 2017 paroxetine mesylate Brisdelle Sebela VMS with menopause October 2017 fosamprenavir Lexiva Viiv Healthcare HIV October 2017 continued

7 Drug Pipeline Monthly Update: December 2017 Page 7 Other first generic launches in the past twelve months (continued) adapalene/benzoyl peroxide Epiduo Galderma Acne August 2017 scopolamine Transderm-Scop Sandoz, Baxter Healthcare, Glaxo Consumer Healthcare Motion sickness August 2017 sevelamer carbonate Renvela Genzyme Control serum phosphorus August 2017 melphalan Alkeran Apo Pharma Multiple myeloma/epithelial carcinoma of the ovary July 2017 olopatadine solution Pataday Teva Eye itching June 2017 thyroid tab Armour Thyroid Actavis Hypothyroid June 2017 desoximetasone ointment Topicort Taro Skin conditions May 2017 tazarotene cream Tazorac Allergan Plaque psoriasis and acne April 2017 levonorgestrel/ethinyl estradiol Quartette Teva Pregnancy prevention April 2017 venlafaxine extended-release Venlafaxine ER UCB Pharma/Vertical Depression and anxiety April 2017 zileuton extended-release Zyflo CR Chiesi USA Asthma April 2017 prednisolone sodium phosphate oral solution 10 mg/5 ml prednisolone sodium phosphate oral solution 20mg/5mL Millipred Veripred 20 Zylera Zylera Inflammatory conditions March 2017 Inflammatory conditions March 2017 methylphenidate SR 60 mg Ritalin LA Novartis ADHD March 2017 flurandrenolide ointment Cordran Aqua Skin irritation February 2017 lopinavir/ritonavir solution Kaletra AbbVie HIV January 2017 aspirin/dipyridamole Aggrenox Boehringer Ingelheim Reduce risk of stroke January 2017 dexmethylphenidate Focalin XR Novartis ADHD January 2017 rasagiline Azilect Teva Neuroscience Parkinson s disease January 2017 aprepitant Emend Merck/Schering- Plough Chemotherapy induced nausea/vomiting January 2017 * Date usually indicates FDA approval date. The product s launch date is determined by the manufacturer. Generic approvals that do not come to market within three months of approval are listed and dated when they enter the market.

8 Drug Pipeline Monthly Update: December 2017 Page 8 Generics of top selling brand drugs potentially available soon ethinyl estradiol/etonogestrel NuvaRing Organon/Merck & Co Pregnancy prevention April 2018 tadalafil Adcirca Eli Lilly PAH May 2018 memantine extended release Namenda XR Forest/Allergan Alzheimer s disease First half 2018 buprenorphine Butrans Purdue Pain 2018 exenatide Byetta AstraZeneca Diabetes 2018 testosterone Androgel (1.62%) AbbVie Testosterone replacement 2018 loteprednol Lotemax Bausch + Lomb/ Valeant Eye inflammation 2018 difluprednate Durezol Alcon/Novartis Eye inflammation 2018 ganirelix acetate Ganirelix Organon/Merck & Co Infertility 2018 epinephrine EpiPen Merck Anaphylaxis 2018 albuterol sulfate Proventil HFA/ ProAir HFA Merck/Teva Asthma/COPD fluticasone/salmeterol Advair Diskus GSK Asthma/COPD * Expected to market dates are predictions made by Prime based on industry information. References All brand names are property of their respective owners A1 Prime Therapeutics LLC 12/17