molecular mechanisms of fda approved drugs in 2014
TRANSCRIPT
Presented By Facilitated By
ALBIN JOSE.V DR. SHIVALINGE GOWDA K.P.M.Pharm- I H.O.D & Associate Professor
Dept.Of Pharmacology Dept.Of Pharmacology
PESCP PESCP04/15/20231
EVALUATION SEMINAR ONMOLECULAR MECHANISMS OF FDA APPROVED DRUGS
IN 2014
04/15/2023
FDA APPROVED DRUGS IN 2014
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1. Dyloject - Diclofenac sodium Injection
2.Namzaric - Donepezil and memantine
3.Saxenda - Liraglutide Injection
4.Opdivo - Nivolumab Injection
5.Rapivab - Peramivir Injection
6.Zerbaxa - Ceftolozane and tazobactam Injection
7.Lynparza - Olaparib Capsules
8.Viekira Pak - Ombitasvir/Paritaprevir/Ritonavir with
Dasabuvir Tablets
9.Xtoro -Finafloxacin Otic Suspension
10.Signifor LAR - Pasireotide for Injectable Suspension
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11.Gardasil 9 - Human papillomavirus 9-valent vaccine,
recombinant Injection
12.Blincyto - Blinatumomab Injection
13.Kitabis Pak - Tobramycin Inhalation Solution
14.Onexton - Benzoyl peroxide and clindamycin phosphate
Gel
15.Hysingla ER - Hydrocodone bitartrate Extended-Release
Tablets
16.Lemtrada - Alemtuzumab Injection
17.Xigduo XR - Dapagliflozin and metformin hydrochloride
Extended-Release Tablets
18.Trumenba - Meningococcal group B vaccine
19.Obizur -Antihemophilic factor (recombinant)
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1. Dyloject -Diclofenac sodium Injection
Company: Javelin Pharmaceuticals, Inc.
Approved indication: Pain
Diclofenac sodium injection
It is an intravenous non-steroidal anti-inflammatory drug
(NSAID)
for the management of acute moderate-to-severe pain
in adults.
Molecular Mechanism
1. Inhibition of prostaglandin synthesis by inhibition of
cyclooxygenase (COX)
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2. Namzaric -Donepezil and Memantine Company: Actavis plc and Adamas Pharmaceuticals
Inc. Approved indication : Alzheimer's Disease
Molecular Mechanism1. Memantine hydrochloride - NMDA receptor antagonist 2. Donepezil hydrochloride -acetylcholinesterase inhibitor.3. Saxenda -Liraglutide Injection Company: Novo Nordisk Inc.
Approved indication : Obesity Liraglutide is a once-daily dose Glucagon- peptide-1 (GLP-1) analogue for the
treatment of obesity.
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4. Opdivo - Nivolumab Injection Company: Bristol-Myers Squibb Company
Approved indication: Melanoma – Metastatic Nivolumab is a programmed death receptor-1 (PD-1) blocking antibody for the treatment of advanced melanoma.Molecular mechanism Human IgG4 PD-1 immune checkpoint inhibitor “Nivolumab for treatment of malignant melanoma.5. Rapivab -Peramivir Injection Company: BioCryst Pharmaceuticals, Inc.
Approved indication: Influenza
Peramivir is an influenza virus neuraminidase inhibitor Indicated for the treatment of acute uncomplicated influenza in
adults.
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Mechanism of Action: Peramivir is a cyclopentane analogue It competitively binds to the active site of the influenza virus neuraminidase. Peramivir inhibits the neuraminidase activity of several strains of influenza A and
B viruses, including H1N1 influenza A (swine influenza).
6. Zebra -Ceftolozane and Tazobactam Injection
Company: Cubist Pharmaceuticals, Inc. Approved indication: Intraabdominal Infection, Urinary Tract Infection
Ceftolozane and Tazobactam is a cephalosporin and beta-lactamase inhibitor combination for the treatment of complicated intra-abdominal infections (cIAI) and complicated urinary tract infections (cUTI).
Molecular mechanism
Ceftolozane-Inhibit the cell wall synthesis.
Tazobactum-Beta-lactamase inhibitor.
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7.Lynparza-Olaparib Capsules
Company: AstraZeneca Approved indication: Ovarian Cancer
Mechanism of Action:
Poly adenosine 5’-diphospho ribose polymerase (PARP) family inhibitor PARP-1 PARP- 2 PARP-3.
8. Viekira Pak -Ombitasvir/Paritaprevir/Ritonavir with Dasabuvir Tablets
Company: AbbVie Inc. Approved indication: Chronic Hepatitis C
Viekira Pak for the treatment of patients with genotype 1 chronic hepatitis C virus (HCV) infection.
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Mechanism of actionOmbitasvir - NS5A inhibitor with potent pangenotypic picomolar
antiviral activityParitaprevir - Inhibitor of the NS3/4A serine proteaseRitonavir – Potent inhibitor of CYP3A4 enzymesDasabuvir - Nonnucleoside NS5B polymerase inhibitor and also used
for pharmacologic booster paritaprevir9. Soolantra -Ivermectin Cream Company: Galderma Laboratories, L.P.
Approved indication: Acne Rosacea Lvermectin is a topical antiparasitic with anti-inflammatory properties
for the treatment of rosacea potentially caused by the microscopic skin mite Demodex folliculorum.
Molecular mechanism Anthelmintic drug- Inhibiting neuronal activity and muscular
contractility in arthropods and nematodes By activating glutamate-gated chloride channels (GluClRs) at
nanomolar concentrations
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10.Xtoro -Finafloxacin Otic Suspension Company: Alcon Laboratories, Inc. Approved indication : Otitis ExternaFinafloxacin Otic suspension is a fluoroquinolone
antimicrobial for the treatment of acute otitis externa, commonly known as swimmer’s ear.
Molecular mechanism Quinolones-Inhibit the enzyme bacterial DNA
gyrase.11.Signifor LAR -Pasireotide for Injectable
Suspension Company: Novartis
Approved indication: Acromegaly Pasireotide is a long acting a somatostatin analog
formulation for the treatment of patients with acromegaly.
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Molecular mechanism1. Pasireotide activates somatostatin receptors,
exhibiting a much higher binding affinity for Somatostatin receptors 1, 3, and 5 than octreotide
in vitro, as well as a comparable binding affinity for somatostatin receptor 2. The binding and activation of the somatostatin
receptors causes inhibition of ACTH secretion and results in reduced cortisol secretion in
Cushing's disease patients. Also this agent is more
potent than somatostatin in inhibiting the release of human growth hormone (HGH),
glucagon, and insulin.
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12.Gardasil 9 -Human papillomavirus 9-valent vaccine,
recombinant Injection
Company: Merck & Co., Inc.
Approved indication: Human Papillomavirus
Prophylaxis
Human papillomavirus 9-valent vaccine, recombinant) is a 9-
valent HPV vaccine for the prevention of cervical, vulvar,
vaginal, and anal cancers caused by HPV types 6, 11, 16, 18,
31, 33, 45, 52 and 58.
13.Blincyto -Blinatumomab Injection
Company: Amgen Inc.
Approved indication: Acute Lymphoblastic
Leukemia
Blinatumomab is a bispecific CD19-directed CD3 T-cell engager
indicated for the treatment of Philadelphia chromosome-
negative relapsed or refractory B-cell precursor acute
lymphoblastic leukemia (ALL).
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Molecular mechanism A molecule of Blinatumomab combines two binding sites: CD3 site for T cells and CD19 site for the target B cells. CD3 is part of the T cell receptor. The drug works by linking these two cell types activating the T cell to exert cytotoxic activity on the target
cell.14.Kitabis Pak -Tobramycin Inhalation Solution Company: PulmoFlow, Inc.
Approved indication: Cystic Fibrosis Tobramycin is an aminoglycoside inhalation solution co-
packaged with a PARI LC PLUS® Reusable Nebulizer for the management of cystic fibrosis.
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Molecular mechanism Tobramycin binding to a site on the
bacterial 30S and 50S ribosome, preventing formation of the 70S complex. As a result, mRNA cannot be translated into protein
and cell death .15.Onexton-Benzoyl peroxide and Clindamycin
phosphate Gel Company: Valeant Pharmaceuticals
International, Inc. Approved indication: Acne
Benzoyl peroxide and Clindamycin phosphate is an antimicrobial and lincosamide antibacterial combination for the once-daily topical treatment of acne vulgaris
04/15/202315
Molecular mechanismClindamycin: It is a lincosamide antibacterial. Benzoyl Peroxide: Benzoyl peroxide is an oxidizing
agent with bacteriocidal and keratolytic effects, but the precise mechanism of action is unknown.
16.Hysingla ER-Hydrocodone bitartrate Extended-
Release Tablets Company: Purdue Pharma L.P.
Approved indication: Chronic Pain Hydrocodone is a single-entity (without
acetaminophen) extended-release opioid analgesic for around-the-clock management of moderate to severe chronic pain.
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Molecular mechanism As a narcotic, Hydrocodone relieves pain by binding to Opioid
receptors in the CNS. It acts primarily on μ-opioid receptors, with about six times lesser
affinity to δ-opioid receptors. In blood, 20–50% of hydrocodone is bound to protein.
17.Lemtrada-Alemtuzumab Injection
Company: Genzyme Approved indication: Multiple Sclerosis
Alemtuzumab is a CD52-directed cytolytic monoclonal antibody indicated for the treatment of relapsing forms of multiple sclerosis (MS).
Molecular mechanism Alemtuzumab is a humanized mAb, which targets the surface
molecule CD52 on all T cell populations and other cellular components of the immune system such as thymocytes, B cells, and monocytes.
Alemtuzumab, which is administered intravenously, depletes T as well as B lymphocyte populations for extended periods.
Adverse effects in MS patients such as thyroid disorders and
idiopathic thrombocytopenic purpura.
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18.Xigduo XR -Dapagliflozin and Metformin hydrochloride Extended-Release Tablets
Company: AstraZeneca Approved indication: Diabetes Type 2
Xigduo XR (Dapagliflozin and Metformin hydrochloride)
It is a once-daily sodium-glucose cotransporter 2 (SGLT2) inhibitor and biguanide combination for the treatment of type 2 diabetes.
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Molecular mechanism Dapagliflozin – Inhibits subtype 2 of the sodium-glucose transport
proteins (SGLT2) which are responsible for at least 90% of the
glucose reabsorption in the kidney. Blocking this transporter mechanism causes blood glucose to be
eliminated through the urine.Metformin Metformin decreases hyperglycemia primarily by suppressing
glucose production by the liver (hepatic gluconeogenesis). 19.Trumenba -meningococcal group B vaccine Company: Pfizer Inc.
Approved indication: Meningococcal Meningitis Prophylaxis
Trumenba (Meningococcal group B vaccine) is indicated for active immunization to prevent invasive disease caused by Neisseria
meningitidis serogroup B in adolescents and young adults.