New Drugs

New Drugs 2015

 • Edoxaban – Oral factor Xa inhibitor approved for DVT, pulmonary embolism and stroke prophylaxis in atrial fibrillation.

 • Secukinumab – Anti IL 17 Ab approved for Psoriasis

 • Isavuconazonium – Azole approved for invasive Aspergillosis and mucormycosis

 • Avibactam – With Ceftazidime

 • Panobinostat – Histone deacetylase inhibitor for multiple myeloma.

 • Cobicistat – Its a CYP3A4 inhibitor approved for use with Atazanavir and Darunavir to increase their half life.

 • Palbociclib – Cyclin dependent kinase inhibitor approved for ER/PR positive breast in post menopausal female in combination with aromatase inhibitor.

 • Lenvatinib – VEGFR TK inhibitor approved for recurrent or metastatic thyroid ca refractory to I131.

 • Nivolumab – Anti PD1 receptor Ab approved for metastatic squammous non small cell ca lung.

 • Dinutuximab – Anti GD2 glycolipid Ab approved for neuroblastoma.

 • Ivabridine – Inhibitor of If current in SA node… Approved for CHF and angina.

 • Sacubitril – Inhibitor of neutral endopeptidase (neprilysin), combined with ARB for treatment of CHF.

• Alirocumab – Anti PCSK 9 Ab used to decrease LDL in familial hypercholesterolemia and CVS atherosclerotic disorders. PCSK 9 is a protein responsible for LDL receptors degradation in liver.

 • Sonidegib – Hedgehog pathway inhibitor used for treatment of basal cell carcinoma recurrence after surgery and radiotherapy.

• Flibanserin – 5HT 1A agonist and 5HT 2C antagonist for hypoactive sexual desire disorder (HSDD).

• Paritaprevir – It is a Hep C virus protease inhibitor.

• Daclatasvir, Ombitasvir – NS5A protein inhibitors of hep C virus.

1. Daclatasvir is approved to be used with sofosbuvir for Hep C infection.

2. Ombitasvir is approved to be used with paritaprevir and ritonavir for Hep C virus infection.

 • Brexpiprazole – Atypical antipsychtic approved for treatment of schizophrenia and depression.

New Drugs 2014

 Apremilast:

• PDE 4 inhibitor
• Psoriatic arthritis

Epanova (omega-3 carboxylic acid):
• Inhibits acyl coA and 1,2 diacylglycerol acetyl transferase
• Used for treatment of severe hypertriglyceridemia

Eliglustat:
• Inhibitor of glucosyl ceramide synthase
• Used for treatment of Gauchers ds type 1

Elosulfase alpha:
• It is recombinant N-acetylglucosamine-6 – sulfatase
• Used for treatment of Mucopolysaccharoidosis IVa

Vorapaxar:
• inhibts thrombin and thrombin receptor agonist peptide (TRAP) induced aggregation by inhibiting PAR 1 receptors (protease activated receptor 1) in platelets.
• Used as an antiaggregant to prevent MI and stroke.

Efinaconazole:
• Azole approved for onychomycosis.

Tavaborole:
• Inhibits synthesis of fungal protein by inhibiting RNA synthase
• Used for toe nail infection.

Oritavancin:
• Inhibits peptide precursor of peptidoglycan and inhibits cell wall unit formation
• Used for gram + bacterial skin infection

Tedizolid:
• Used for treatment of bacterial skin infection including MRSA.

Afrezza:
• Inhalational powdered insulin for post prandial hyperglycemia.
• S/E – Bronchoconstriction

Canagliflozin
Dapagliflozin
Empagliflozin
• Used for DM II
• S/E – UTI

Albiglutide:
• GLP 1 agonist

Eliglustat:
• Inhibitor of glucosyl ceramide synthase
• Used for treatment of Gauchers ds type 1

Suvorexant:
• Orexin receptor antagonist (Orexin maintains wakefulness)
• Used for treatment of insomnia

Vedolizumab:
• Anti alpha 4 beta 7 integrin Ab
• IBD

Ramucirumab:
• Anti VEGFR Ab
• Gastric cancer post or pre cisplatin

Belinostat:
• Histone deacetylase inhibitor
• Used for peripheral T cell lymphoma

Ibrutinib:
• Brutons Tk inhibitor
• CLL

Siltuximb:
• Anti IL 6 Ab
• Multicentric Castleman’s disease

Idelalisib:
• Phisphoinositide 3 kinase (PI3K) inhibitor
• Relapsed CLL, NHL and SLL

Ceritinib:
• Anaplastic lymphoma kinase inhibitor
• ALK + non small cell ca of lung

Metreleptin:
• Leptin analog
• Lipodystrophy

Umeclidinum:
• Long acting antimuscarinic
• OD dose for COPD

Olodaterol:
• Long acting beta 2 agonist
• OD dose for COPD

Nalexogol:
•Mui opioid receptor antagonist.
•Approved for treatment of opioid induced constipation.

Ferric citrate:
• Use – Hyperphosphatemia in CKD.
• Binds to phosphate in GIT, forms ferric phosphate and inhibits absorption.

Pembrolizumb:

• Anti PD1 receptor antibody.
• Use – Malignant melanoma

Bupropion + Naltrexone combination:
• Approved for obesity treatment

Drugs approved in 2014

• Elbasvir + Grazoptevir FDC for HCV genotype 1 or 4
1. Elbasvir = Hep C NS5A inhibitor
2. Grazoprevir = Hep C Protease inhibitor

• Ixekizumab – Anti IL-17 Ab approved for Psoriasis.

• Nivolumab – Anti PD-1 Ab approved for Hodgkin’s lymphoma. PD-1 protein inhibition decreases T-cell activation and cytokine production.

• Venetoclax – Atiapoptotic protein Bcl-2 inhibitor used for CLL with 17p deletion.

• Velpatasvir – Hep C NS5A phosphoprotein inhibitor. Approved to be used with sofosbuvir.

• Obiltoxaximab – Anti Anthrax Ab

• Daclizumab – Anti IL-2 Ab for RRMS.

• Lenvatinib – Anti VEGFR Ab for RCC with everolimus

• Brivarcetam – SV2A inhibitor for partial seizure

• Pimavanserin – Atypical antipsychotic for hallucination and delusion associated with Parkinson’s disease.

• Cabozabtinib – Multi tyrosine kinase inhibitor for RCC

• Atezolizumab – Anti PD-L1 Ab for urothelial carcinoma

• Reslizumab – Anti IL-5 Ab for severe asthma as add on drug. IL-5 increases survivability of eosinophils.