Write a paper that provides an update on biological chemistry and pharmacology of a rec

BIOL 409-509 Pharmacology Principles and Applications

Fall 2020

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Paper 2: Update on a recently approved drug

Paper 2 Assignment: Write a paper that provides an update on biological chemistry and pharmacology of a recently approved drug (choices to be provided): You have landed a job as a lab research scientist. The head of the lab is interested in a particular class of drug and asks you to write a mini-review (1500 words or more, may include figures/tables/diagrams from literature) for other scientists in the lab. Write your paper based on class discussions and key literature (two or more papers) to be provided by the instructor.

You may choose from the list provided below in this document. You will also find articles and other resources in D2L for each of the drugs listed below.


Alternatively, you can choose another drug from lists maintained by the Food and Drug Administration (FDA), such as novel drug approvals for 2020



Or 2019

https://www.fda.gov/drugs/new-drugs-fda-cders-new-molecular-entities-and-new-therapeutic-biological-products/novel-drug-approvals-2019 or https://www.centerwatch.com/drug-information/fda-approved-drugs/


Or earlier years (2018, 2017, 2016, 2015).



List of some recently approved drugs (2015). See D2L for more information and resources.



1. Nucala (mepolizumab) – A humanized interleukin-5 antagonist monoclonal antibody (IgG1 kappa) for add-on maintenance treatment of patients with severe asthma aged 12 years and older, and with an eosinophilic phenotype. http://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm471031.htm ; http://www.centerwatch.com/drug-information/fda-approved-drugs/drug/100110/nucala-mepolizumab ; Pricing review http://www.icer-review.org/icer-draft-reports-on-nucala-mepolizumab-for-asthma-and-tresiba-insulin-degludec-for-diabetes-posted-for-public-comment/ ; http://www.pmlive.com/pharma_news/nucala_price_far_too_high_for_us_market,_says_icer_892078


2. Corlanor (ivabradine) – Corlanor (ivabradine) is a hyperpolarization-activated cyclic nucleotide-gated (HCN) channel blocker. This channel is responsible for the cardiac pacemaker If current, which regulates heart rate. Ivabradine reduces the spontaneous pacemaker activity of the cardiac sinus node by selectively inhibiting the If current (If), also known as the “funny” current”, resulting in heart rate reduction with no effect on ventricular repolarization and no effects on myocardial contractility. http://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm442978.htm


3. Entresto (sacubitril/valsartan) – a combined neprilysin inhibitor/angiotensin II blocker for heart failure. ENTRESTO is a combination of sacubitril, a neprilysin inhibitor, and valsartan, an angiotensin II receptor blocker, indicated to reduce the risk of cardiovascular death and hospitalization for heart failure in patients with chronic heart failure (NYHA Class II-IV) and reduced ejection fraction. ENTRESTO inhibits neprilysin (neutral endopeptidase; NEP) via LBQ657, the active metabolite of the prodrug sacubitril, and blocks the angiotensin II type-1 (AT1) receptor via valsartan. http://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm453845.htm ; https://www.novartis.com/news/media-releases/novartis-heart-failure-medicine-entrestotm-receives-eu-approval ; Pricing review http://www.icer-review.org/chf-draft-report-posted/ , http://www.fiercepharma.com/story/novartis-priced-entresto-par-results-new-cost-watchdog-says/2015-09-14


4. Repatha (evolocumab)- PCSK9 inhibitor for high cholesterol (hypercholesterolemia). Evolocumab is a human monoclonal IgG2 directed against human proprotein convertase subtilisin kexin 9 (PCSK9). Evolocumab binds to PCSK9 and inhibits circulating PCSK9 from binding to the low density lipoprotein (LDL) receptor (LDLR), preventing PCSK9-mediated LDLR degradation and permitting LDLR to recycle back to the liver cell surface. By inhibiting the binding of PCSK9 to LDLR, evolocumab increases the number of LDLRs available to clear LDL from the blood, thereby lowering LDL-C levels. http://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm460082.htm ; http://www.centerwatch.com/drug-information/fda-approved-drugs/drug/100092/repatha-evolocumab- ; https://ghr.nlm.nih.gov/gene/PCSK9 ; Pricing review – http://www.icer-review.org/pcsk9-draft-report-release/ ; http://www.pmlive.com/pharma_news/pricing


5. Kybella (deoxycholic acid) – is a non-human and non-animal formulation of deoxycholic acid, a naturally-occurring molecule in the body that aids in the breakdown and absorption of dietary fat, injected below the chin to reduce submental fat. KYBELLA is a cytolytic drug indicated for improvement in the appearance of moderate to severe convexity or fullness associated with submental fat in adults.

http://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm444978.htm ; http://www.centerwatch.com/drug-information/fda-approved-drugs/drug/100077/kybella-deoxycholic-acid

6. Kanuma (sebelipase alfa) – recombinant human lysosomal acid lipase (rhLAL) that catalyzes cholesterol esters and triglycerides. Patients with deficiency in LAL (e.g., Wolman disease) have no or little LAL enzyme activity which results in accumulation of fats in the cells of various tissues that can lead to liver and cardiovascular disease. http://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm476013.htm ; http://www.centerwatch.com/drug-information/kanuma-sebelipase-alfa ;http://www.omim.org/entry/278000 ;

7. Tanzeum (Albiglutide) – is a GLP-1 agonist to improve glycemic control, along with diet and exercise, in adults with type 2 diabetes. Tanzeum augments glucose-dependent insulin secretion and slows gastric emptying.

http://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm393289.htm ;


8. Imlygic (talimogene laherparepvec) – IMLYGIC is a genetically modified oncolytic viral therapy indicated for the local treatment of unresectable cutaneous, subcutaneous, and nodal lesions in patients with melanoma recurrent after initial surgery. IMLYGIC has been genetically modified to replicate within tumors and to produce the immune stimulatory protein GM-CSF. IMLYGIC causes lysis of tumors, followed by release of tumor-derived antigens, which together with virally derived GM-CSF may promote an antitumor immune response. surgery.http://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm469571.htm ; http://www.centerwatch.com/drug-information/fda-approved-drugs/drug/100101/imlygic-talimogene-laherparepvec-


9. Opdivo (nivolumab) – a programmed death receptor-1 (PD-1) blocking antibody indicated for the treatment as a single agent, of patients with BRAF V600 wild-type unresectable or metastatic melanoma. Surface expression and binding of the PD-1 protein ligands, PD-L1 and PD-L2, by cancer cells to the PD-1 receptor found on T cells, inhibits T-cell proliferation and cytokine production. Upregulation of PD-1 ligands occurs in some tumors and signaling through this pathway can contribute to inhibition of active T-cell immune surveillance of tumors. Nivolumab is a human immunoglobulin G4 (IgG4) monoclonal antibody that binds to the PD-1 receptor and blocks its interaction with PD-L1 and PD-L2, releasing PD-1 pathway-mediated inhibition of the immune response, including the anti-tumor immune response. In syngeneic mouse tumor models, blocking PD-1 activity resulted in decreased tumor growth. http://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm427716.htm


10. Otezla (Apremilast) – Phosphodiesterase 4 inhibitor to treat adults with active psoriatic arthritis (PsA). http://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm390091.htm


11. Kadcyla (ado-trastuzumab emtansine) – is a new antibody drug conjugate therapy for patients with HER2-positive, late-stage (metastatic) breast cancer. Ado-trastuzumab emtansine is a HER2-targeted antibody-drug conjugate. The antibody is the humanized anti-HER2 IgG1, trastuzumab. The small molecule cytotoxin, DM1, is a microtubule inhibitor. Upon binding to sub-domain IV of the HER2 receptor, ado-trastuzumab emtansine undergoes receptor-mediated internalization and subsequent lysosomal degradation, resulting in intracellular release of DM1-containing cytotoxic catabolites. Binding of DM1 to tubulin disrupts microtubule networks in the cell, which results in cell cycle arrest and apoptotic cell death. http://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm340704.htm ; https://www.nice.org.uk/news/press-and-media/nice-kadcyla-price-still-too-high ; http://articles.economictimes.indiatimes.com/2015-11-26/news/68582313_1_perjeta-kadcyla-herceptin


12. Belsomra (Suvorexant) – Suvorexant is an orexin receptor antagonist indicated for the treatment of insomnia, characterized by difficulties with sleep onset and/or sleep maintenance. http://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm409950.htm


13. Entyvio (vedolzumab) – is an injection to treat adult patients with moderate to severe ulcerative colitis and adult patients with moderate to severe Crohn‘s disease. Vedolizumab is a humanized monoclonal antibody that specifically binds to the α4β7 integrin and blocks the interaction of α4β7 integrin with mucosal addressin cell adhesion molecule-1 (MAdCAM-1) and inhibits the migration of memory T-lymphocytes across the endothelium into inflamed gastrointestinal parenchymal tissue. Vedolizumab does not bind to or inhibit function of the α4β1 and αEβ7 integrins and does not antagonize the interaction of α4 integrins with vascular cell adhesion molecule-1 (VCAM-1). http://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm398065.htm


14. Zontivity (vorapaxar) – is a protease-activated receptor-1 (PAR-1) antagonist indicated for the reduction of thrombotic cardiovascular events in patients with a history of myocardial infarction (MI) or with peripheral arterial disease (PAD). http://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm396585.htm


Some recently approved drugs for 2019

1. Nourianz (istradefylline) is an adenosine 2A antagonist used to treat off symptoms of Parkinson’s disease. On August 27, 2019, the U.S. Food and Drug Administration approved Nourianz (istradefylline) tablets as an add-on treatment to levodopa/carbidopa in adult patients with Parkinson’s disease (PD) experiencing “off” episodes. An “off” episode is a time when a patient’s medications are not working well, causing an increase in PD symptoms, such as tremor and difficulty walking. https://www.fda.gov/news-events/press-announcements/fda-approves-new-add-drug-treat-episodes-adults-parkinsons-disease


2. Rinvoq (upadacitinib) is a Janus Kinase (JAK) inhibitor. Rinvoq is specifically indicated for the treatment of adults with moderately to severely active rheumatoid arthritis who have had an inadequate response or intolerance to methotrexate. Rinvoq is supplied as an extended release capsule for oral administration. The recommended oral dose of Rinvoq is 15 mg once daily with or without food. Rinvoq may be used as monotherapy or in combination with methotrexate or other nonbiologic DMARDs. https://www.centerwatch.com/drug-information/fda-approved-drugs/drug/100420/rinvoq-upadacitinib

a. Label & other materials https://www.accessdata.fda.gov/scripts/cder/daf/index.cfm?event=overview.process&varApplNo=211675


3. Mayzent (siponimod) is a sphingosine1-phosphate receptor modulator. It is specifically indicated for the treatment of relapsing forms of multiple sclerosis (MS), to include clinically isolated syndrome, relapsing-remitting disease, and active secondary progressive disease, in adults. Mayzent is supplied as a tablet for oral administration. Prior to administration the following should be assessed for various ADME and safety related endpoints including:

a. CYP2C9 Genotype Determination: Test patients for CYP2C9 variants to determine CYP2C9 genotype. An FDA-cleared or -approved test for the detection of CYP2C9 variants to direct the use of siponimod is not currently available.

b. https://www.centerwatch.com/drug-information/fda-approved-drugs/drug/100367/mayzent-siponimod

c. https://www.fda.gov/news-events/press-announcements/fda-approves-new-oral-drug-treat-multiple-sclerosis


4. Vyndaqel (tafamidis meglumine) and Vyndamax (tafamidis) are oral transthyretin stabilizers. Vyndaqel and Vyndamax are specifically indicated for the treatment of the cardiomyopathy of wild type or hereditary transthyretin-mediated amyloidosis (ATTR-CM) in adults to reduce cardiovascular mortality and cardiovascular-related hospitalization. On May 3, 2019 the U.S. Food and Drug Administration approved Vyndaqel (tafamidis meglumine) and Vyndamax (tafamidis) capsules for the treatment of the heart disease (cardiomyopathy) caused by transthyretin mediated amyloidosis (ATTR-CM) in adults. These are the first FDA-approved treatments for ATTR-CM. Vyndaqel and Vyndamax have the same active moiety, tafamidis, but they are not substitutable on a milligram to milligram basis and their recommended doses differ. “Transthyretin-mediated amyloidosis is a rare, debilitating and often fatal disease,” said Norman Stockbridge, M.D., Ph.D., director of the Division of Cardiovascular and Renal Drugs in the FDA’s Center for Drug Evaluation and Research. “The treatments we’re approving today are an important advancement in the treatment of the cardiomyopathy caused by transthyretin-mediated amyloidosis.”

a. https://www.fda.gov/news-events/press-announcements/fda-approves-new-treatments-heart-disease-caused-serious-rare-disease-transthyretin-mediated

b. https://www.centerwatch.com/drug-information/fda-approved-drugs/drug/100383/vyndaqel-tafamidis-meglumine-and-vyndamax-tafamidis-

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