New drugs approved in 2013

Guest article by Dr. Gobind Rai Garg.



  • Riociguat is a stimulator of soluble guanylate cyclase (sGC), an enzyme in the cardiopulmonary system and the receptor for nitric oxide (NO). These stimulators help arteries relax to increase blood flow and decrease blood pressure. It is specifically indicated for persistent/recurrent Chronic Thromboembolic Pulmonary Hypertension (CTEPH) (WHO Group 4) after surgical treatment or inoperable CTEPH to improve exercise capacity and WHO functional class and Pulmonary Arterial Hypertension (PAH) (WHO Group 1) to improve exercise capacity, improve WHO functional class and to delay clinical worsening.
  • Trametinib is an orally bioavailable inhibitor of mitogen-activated protein kinase kinase (MEK) with potential antineoplastic activity. Trametinib specifically binds to and inhibits MEK 1 and 2, resulting in an inhibition of growth factor-mediated cell signaling and cellular proliferation in various cancers. MEK 1 and 2, dual specificity threonine/tyrosine kinases often upregulated in various cancer cell types, play a key role in the activation of the RAS/RAF/MEK/ERK signaling pathway that regulates cell growth. It is specifically indicated for the treatment of patients with unresectable or metastatic melanoma with BRAF V600E or V600K mutations as detected by an FDA-approved test. It is not indicated for patients who have received prior BRAF-inhibitor therapy.
  • Canagliflozin is a sodium-glucose co-transporter 2 (SGLT2) inhibitor. Inhibiting SGLT2 is believed to reduce blood glucose levels by increasing the amount of glucose excreted in the urine. It is specifically indicated as an adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes mellitus/
  • Tocilizumab is a humanized anti IL-6 receptor monoclonal antibody. It binds specifically to IL-6 receptors. IL-6 is a pro-inflammatory cytokine produced by a variety of cell types, including T- and B-cells, lymphocytes, monocytes and fibroblasts. It is specifically approved for patients 2 years of age and older with active polyarticular juvenile idiopathic arthritis.
  • Canakinumab is a human monoclonal anti-human IL-1ß antibody. Canakinumab binds to human IL­1ß and neutralizesits activity by blocking its interaction with IL-1 receptors, but it does not bind IL-1a or IL-1 receptor antagonist (IL-1ra). It is specifically indicated for the treatment of active Systemic Juvenile Idiopathic Arthritis (SJIA) in patients aged 2 years and older.
  • Dimethyl fumarate is an oral, small molecule immune modulator. The mechanism by which dimethyl fumarate exerts its therapeutic effect in multiple sclerosis is unknown. However, it has been postulated that dimethyl fumarate has the potential to reduce the activity and impact of inflammatory cells on the central nervous system (CNS) and induce direct cytoprotective responses in CNS cells. It is specifically indicated for the treatment of adults with relapsing forms of multiple sclerosis.
  • Pomalidomide is an immunomodulatory antineoplastic agent. It inhibits proliferation and induces apoptosis of hematopoietic tumor cells, enhances T cell- and natural killer cell-mediated immunity and inhibits production of pro-inflammatory cytokines by monocytes. It is specifically indicated for patients with multiple myeloma who have received at least two prior therapies including lenalidomide and bortezomib and have demonstrated disease progression on or within 60 days of completion of the last therapy.
  • Lenalidomide, a thalidomide analogue, is an immunomodulatory agent with antiangiogenic and antineoplastic properties. It is specifically indicated forr the treatment of patients with mantle cell lymphoma (MCL) whose disease has relapsed or progressed after two prior therapies, one of which included bortezomib.
  • Telavancin is a semisynthetic, lipoglycopeptide antibiotic. It inhibits cell wall biosynthesis and disrupts membrane barrier function. It is specifically indicated for the treatment of adult patients with hospital-acquired and ventilator-associated bacterial pneumonia (HABP/VABP), caused by susceptible isolates of Staphylococcus aureus (including methicillin-susceptible and -resistant isolates). Vibativ should be reserved for use when alternative treatments are not suitable.
  • Cysteamine bitartrate delayed-release capsules is a cystine depleting agent which lowers the cystine content of cells in patients with nephropathic cystinosis, an inherited defect of lysosomal transport. It is specifically indicated for the management of nephropathic cystinosis in adults and children ages 6 years and older.
  • Levomilnacipran is an extended release selective norepinephrine and serotonin reuptake inhibitor. It is specifically indicated for the treatment of Major Depressive Disorder.
  • Afatinib is a tyrosine kinase inhibitor of EGFR (ErbB1), HER2 (ErbB2), and HER4 (ErbB4). It is specifically indicated for the first-line treatment of patients with metastatic non-small cell lung cancer whose tumors have epidermal growth factor receptor (EGFR) exon 19 deletions or exon 21 (L858R) substitution mutations as detected by an FDA-approved test.
  • Regorafenib is a small molecule inhibitor of multiple membrane-bound and intracellular kinases involved in normal cellular functions and in pathologic processes such as oncogenesis, tumor angiogenesis, and maintenance of the tumor microenvironment. It is specifically indicated for patients with locally advanced, unresectable or metastatic gastrointestinal stromal tumor who have been previously treated with imatinib mesylate and sunitinib malate.
  • Vortioxetine is a serotonin modulator and stimulator. It belongs to a psychotropic class of chemical compunds known as bis-aryl-sulphanyl amines. It is specifically indicated for Major Depressive Disorder.
  • Once daily topical gel formulation of brimonidine, an alpha-2 adrenergic agonist with potent vasoconstrictive activity is specifically indicated for the topical treatment of persistent (nontransient) erythema of rosacea in adults 18 years of age or older.
  • Dabrafenib is an inhibitor of some mutated forms of BRAF kinases, as well as wild-type BRAF and CRAF kinases. Some mutations in the BRAF gene, including those that result in BRAF V600E, can result in constitutively activated BRAF kinases that may stimulate tumor cell growth. It is specifically indicated for the treatment of patients with unresectable or metastatic melanoma with BRAF V600E mutation as detected by an FDA-approved test. It is not indicated for treatment of patients with wild-type BRAF melanoma.
  • A gel formulation of mechlorethamine, an alkylating agent which inhibits rapidly proliferating cells is specifically indicated for the topical treatment of Stage IA and IB mycosis fungoides-type cutaneous T-cell lymphoma in patients who have received prior skin-directed therapy. A low-dose formulation of paroxetine mesylate, a selective serotonin reuptake inhibitor is specifically indicated for the treatment of moderate to severe vasomotor symptoms associated with menopause.
  • Denosumab is a human IgG2 monoclonal antibody that binds to human RANKL. Increased osteoclast activity, stimulated by RANKL, is a mediator of bone pathology in solid tumors with osseous metastases. It is specifically indicated for the treatment of adults and skeletally mature adolescents with giant cell tumor of bone that is unresectable or where surgical resection is likely to result in severe morbidity.
  • Radium Ra 223 dichloride, an alpha particle-emitting pharmaceutical, is a radiotherapeutic drug. It is specifically indicated for the treatment of patients with castration-resistant prostate cancer, symptomatic bone metastases and no known visceral metastatic disease.
  • Dolutegravir is an integrase inhibitor. It blocks HIV replication by preventing viral DNA from integrating into the genetic material of human immune cells (T-cells). It is specifically indicated in combination with other antiretroviral agents for the treatment of human immunodeficiency virus type 1 (HIV-1) infection in adults and children aged 12 years and older and weighing at least 40 kg.

Popular posts from this blog

PG Doctors of India must work not more than 48 Hr/week: SC

Indian Media in Bed with Politicans

Best PG Entrance Coaching - Opinion Poll Results