Ipilimumab-Latest drug for Advanced Melanoma

March 25, 2011 — The US Food and Drug Administration (FDA) announced today the approval of ipilimumab (Yervoy, Bristol-Myers Squibb) for the treatment of advanced melanoma as a second-line therapy.


"Late-stage melanoma is devastating, with very few treatment options for patients, none of which previously prolonged a patient's life," said Richard Pazdur, MD, director of the Office of Oncology Drug Products in the FDA's Center for Drug Evaluation and Research. Ipilimumab "is the first therapy approved by the FDA to clearly demonstrate that patients with metastatic melanoma live longer by taking this treatment."


Ipilimumab is another targeted therapy for cancer, but represents a new class of drug, known as a targeted T cell antibody, Ipilimumab is directed against an antigen on the surface of T cells. The antigen, cytotoxic T lymphocyte–associated antigen 4 (CTLA-4), acts as a brake on the T cell, By blocking the brake, the T cell goes into attack mode and kills cancer cells.


The FDA noted in its approval announcement that the common adverse effects that can result from autoimmune reactions associated with ipilimumab use include fatigue, diarrhea, skin rash, endocrine deficiencies (gland or hormone), and inflammation of the intestines (colitis). Severe to fatal autoimmune reactions were seen in 12.9% of patients treated with ipilimumab. When severe adverse effects occurred, the drug was stopped and corticosteroid treatment was started


source:medscape

FDA Approves Zoster Vaccine for Younger Adults

March 24, 2011 — The US Food and Drug Administration (FDA) announced today approval for a vaccine to prevent herpes zoster, also known as shingles, in adults age 50 to 59 years.

The vaccine (Zostavax, Merck & Co., Inc.), a live attenuated virus vaccine, was already approved for prevention of zoster in adults 60 years of age and older in May 2006.

"The likelihood of shingles increases with age. The availability of Zostavax to a younger age group provides an additional opportunity to prevent this often painful and debilitating disease," said Karen Midthun, MD, director of FDA's Center for Biologics Evaluation and Research, in a news release.

The most common side effects observed were redness, pain, and swelling at the site of injection and headache.

source:medscape

New Drug for overactive bladder syndrome

 Mirabegron, the first in a new class of beta-3 adrenoceptor agonists to treat patients with overactive bladder syndrome (OAB), significantly reduces the incidence of urinary incontinence and micturition, according to results from 2 phase 3 studies presented here at the European Association of Urology 26th Annual Congress.

At once-daily doses of 50 and 100 mg, mirabegron was superior to placebo in the treatment of OAB, was well tolerated in the study populations, and demonstrated the promising therapeutic potential of this new class of drugs in the treatment of this syndrome.

Of particular interest with mirabegron, as a first-in-class drug, are drug-related adverse events. "There were no significant cardiovascular events in the mirabegron group. Overall incidence of hypertension was similar across groups, and there was no effect on the [electrocardiogram] cycle QT interval. That's important because certain drugs can affect this and lead to cardiac risks

source:medscape

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Doripenem

Doripenem belongs to the carbapenem class of antimicrobials. Doripenem exerts its bactericidal activity by inhibiting bacterial cell wall biosynthesis. Doripenem inactivates multiple essential penicillin-binding proteins (PBPs) resulting in inhibition of cell wall synthesis with subsequent cell death. In E. coli and P. aeruginosa, doripenem binds to PBP 2, which is involved in the maintenance of cell shape, as well as to PBPs 3 and 4.


Doripenem  is specifically indicated for the treatment of the following infections caused by designated susceptible bacteria: complicated intra-abdominal infections and complicated urinary tract infections, including pyelonephritis. 


source:centerwatch

Biomarker Panel Identifies Asthma, COPD

A combination of 4 blood proteins may serve as biomarkers to help clinicians distinguish patients with asthma from those with chronic obstructive pulmonary disease (COPD), Australian researchers report. These proteins have "the potential to be a valuable tool in the clinical diagnosis of respiratory disease," 


The biomarkers were identified through proteomics, which "can simultaneously identify multiple proteins associated with different disease states and potentially discover novel proteins not previously associated with particular disease states," the authors explain.


The findings suggest that those 4 proteins — ceruloplasmin, haptoglobin, hemopexin, and α-2-macroglobulin — can be used in combination to identify patients with asthma and COPD, the authors write. For example, in the younger patients, the combination of ceruloplasmin and haptoglobin was best for discriminating between asthmatic and healthy control patients, whereas in the older patients, haptoglobin and hemopexin were more effective.


source:medscape

Variant of Protein Is Associated With Type 2 Diabetes

A variant of HMGA1 occurs significantly more often in patients with type 2 diabetes mellitus (DM) who are of white European heritage than in control patients.


The variant, designated IVS5-13insC, impairs function of the HMGA1 protein, a cofactor for gene activation that regulates insulin-receptor gene (INSR) expression. 

The presence of these variants suggests several potential clinical uses:

• as early predictive markers of insulin resistance and type 2 DM;

• to predict response to therapies such as insulin sensitizers;

• to predict the clinical course of type 2 DM, such as the likelihood of macro- and microvascular complications; and

• to indicate patients with type 2 DM for whom targeted therapy could involve agents that upregulate HMGA1 expression.

source:medscape 

Icodextrin- Peritoneal Dialysis Solution

Icodextrin- Peritoneal Dialysis Solution is a peritoneal dialysis solution containing the colloid osmotic agent icodextrin. Icodextrin is a starch-derived, water-soluble glucose polymer linked by alpha (1-4) and less than 10% alpha (1-6) glucosidic bonds with a weight-average molecular weight between 13,000 and 19,000 Daltons and a number average molecular weight between 5,000 and 6,500 Daltons.


Icodextrin is available for intraperitoneal administration only as a sterile, nonpyrogenic, clear solution in 1.5 L, 2.0 L and 2.5 L


Note:Only use glucose-specific monitors and test strips to measure blood glucose levels in patients using Extraneal (icodextrin) Peritoneal Dialysis Solution. Blood glucose monitoring devices using glucose dehydrogenase pyrroloquinolinequinone (GDH-PQQ) or glucose-dye-oxidoreductase (GDO)-based methods must not be used. 


source:rxlist

Belimumab (FDA 2011) for SLE

The US Food and Drug Administration (FDA) has approved the use of belimumab  in combination with standard therapies to treat active autoantibody-positive systematic lupus erythematosus.

This is the first lupus drug to be approved since 1955, when the FDA approved hydroxychloroquine (Plaquenil) and corticosteroids. In 1948, aspirin was approved to treat lupus.

Belimumab is a B-lymphocyte stimulator protein inhibitor that is thought to decrease the amount of abnormal B cells, which is hypothesized to be a mechanism of action in lupus.

Common adverse effects reported with belimumab include nausea, diarrhea, fever, and infusion-site reactions. It is suggested that patients be treated with an antihistamine prior to a belimumab infusion.

Source:medscape

Liraglutide (FDA 2010) for type 2 diabetes

 Liraglutide is an analog of human GLP-1 and acts as a GLP-1 receptor agonist. Liraglutide increases intracellular cyclic AMP (cAMP) leading to insulin release in the presence of elevated glucose concentrations. This insulin secretion subsides as blood glucose concentrations decrease and approach euglycemia. Liraglutide also decreases glucagon secretion in a glucose-dependent manner. The mechanism of blood glucose lowering also involves a delay in gastric emptying.

 Liraglutide is specifically indicated as an adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes mellitus.

Liraglutide is supplied as solution designed for subcutaneous injection. Liraglutide can be administered once daily at any time of day, independently of meals, and can be injected subcutaneously in the abdomen, thigh or upper arm. The recommended initial dose is 0.6 mg per day for one week. After one week at 0.6 mg per day, the dose should be increased to 1.2 mg. If the 1.2 mg dose does not result in acceptable glycemic control, the dose can be increased to 1.8 mg.

source:centerwatch

Fetal Endoscopic Tracheal Occlusion (FETO) for Congenital Diaphragmatic Hernia (CDH)

Fetal Endoscopic Tracheal Occlusion (FETO) for Congenital Diaphragmatic Hernia (CDH)

Fetoscopic therapy has been rigorously evaluated in infants with this condition. With an isolated diaphragmatic hernia and with specialized care and postnatal surgery, mortality rates approximate 30 percent (Reickert and colleagues, 1998). The major prenatal findings used to identify candidates for fetal therapy—those at risk for lethal pulmonary hypoplasia—include a significant amount of liver within the thorax and a low lung-to-head ratio—the cross-sectional area of the right lung divided by the head circumference. 

The rationale for FETO is that by placing a silicone balloon between the fetal carina and vocal cords, the normal egress of lung fluid is halted, and the lungs will expand despite the presence of abdominal organs in the chest. The balloon is removed at delivery via the ex-utero-intrapartum-treatment (EXIT) procedure

Ref:William's obstretics,chapter 15

Mediterranean Diet and Metabolic Syndrome

A diet high in monounsaturated fatty acids, fruits, vegetables, whole-grain cereals, and low-fat dairy products, coupled with fish, poultry, nuts, legumes, and a low consumption of red meat--also known as the Mediterranean diet--is associated with a lower prevalence and slower progression of metabolic syndrome, according to the results of a new meta-analysis.

In addition, adhering to the Mediterranean diet had favorable effects on individual components of the metabolic syndrome, including waist circumference, HDL-cholesterol and triglyceride levels, blood pressure, and glucose metabolism, report investigators.

The results are from a meta-analysis of 35 clinical trials, two prospective studies, and 13 cross-sectional studies and include data on more than 500 000 study participants. Among the clinical trials and prospective studies, adherence to the Mediterranean diet was "highly protective," report investigators, with those subjects adhering to the diet having a 31% lower risk of developing metabolic syndrome.

source:medscape

Vilazodone - FDA 2011

Vilazodone hydrochloride is a selective serotonin reuptake inhibitor and a 5HT1A receptor partial agonist. The mechanism of the antidepressant effect of vilazodone is not fully understood but is thought to be related to its enhancement of serotonergic activity in the CNS through selective inhibition of serotonin reuptake. Vilazodone is also a partial agonist at serotonergic 5-HT1A receptors.

Vilazodone is specifically indicated for the treatment of major depressive disorder.
The recommended initial dose of Viibryd is 40 mg once daily. Treatment should be titrated, starting with an initial dose of 10 mg once daily for 7 days, followed by 20 mg once daily for an additional 7 days, and then an increase to 40 mg once daily.

Source:centerwatch

Plerixafor for Non-Hodgkin's lymphoma and multiple myeloma

Plerixafor is a hematopoietic stem cell mobilizer and inhibitor of the CXCR4 chemokine receptor. CXXR4 is specific for stromal-derived-factor-1 (SDF-1), a molecule endowed with potent chemotactic activity for lymphocytes.
 Because the interaction between SDF-1 and CXCR4 plays an important role in holding
hematopoietic stem cells in the bone marrow, drugs that block the CXCR4 receptor appear to be capable of
"mobilizing" hematopoietic stem cells into the bloodstream.

 Plerixafor in combination with granulocyte-colony stimulating factor (G-CSF), is specifically indicated to mobilize hematopoietic stem cells to the peripheral blood for collection and subsequent autologous transplantation in patients with non-Hodgkin ’s lymphoma (NHL) and multiple myeloma.

Source:centerwatch