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Weekly Drug News Round Up - March 18, 2015

Investigational PCSK-9 Inhibitor Evolocumab: Study

New drugs under study may be added to statin therapy for the hardest-to-treat patients who still have elevated cholesterol, even after statin use Read More…

Repatha (evolocumab) is an investigational PCSK9 (proprotein convertase subtilisin/kexin type 9) monoclonal antibody in development for the treatment of patients with high cholesterol. Studies show that when this biologic drug is added to conventional statin therapy the rates of cardiovascular events like heart attack and stroke can be reduced by over 50 percent. Evolocumab, in a new class of drugs called PCSK9 inhibitors, works by blocking a protein that reduces the liver's ability to remove LDL (''bad'') cholesterol from the blood. These investigational agents are not meant to replace statins, and clinicians await larger scale studies. Sanofi and Regeneron’s Praluent (alirocumab) is another PCSK9 inhibitor in development.

Cholbam Approved for Rare Metabolic Disorders

Cholbam, the first drug approved for these disorders, is OK’d under priority review Read More...

This week the U.S. Food and Drug Administration (FDA) approved Asklepion’s Cholbam (cholic acid), an oral capsule treatment for adult and pediatric patients with bile acid synthesis disorders due to single enzyme defects, or peroxisomal disorders (including Zellweger spectrum disorders). Individuals with these rare disorders lack the enzymes needed to synthesize cholic acid, a primary bile acid normally produced in the liver from cholesterol. The absence of cholic acid in these patients leads to reduced bile flow, liver accumulation of toxic bile acid intermediates (cholestasis), and malabsorption of fats and fat-soluble vitamins. The most common side effect in studies with Cholbam was diarrhea.

Newer Anti-Clotting Agent May Improve Cardiovascular Risk: Study

About 7 percent of the study patients stopped Brilinta due to bleeding, and about 5 percent stopped due to shortness of breath Read More...

Long-term use of the newer anti-clotting drug Brilinta (ticagrelor) cut heart attack survivors' future risk of heart attack, stroke or heart-related death. In a study of more than 21,000 high-risk patients who had survived a heart attack in the previous one to three years, patients randomly received a twice-daily dose of either 90 or 60 milligrams (mg) of Brilinta (ticagrelor), or an inactive placebo. All of them kept taking low-dose aspirin, a standard therapy. Heart attack, stroke and heart-related death risk was 15 percent lower with the 90-mg dose of Brilinta, and 16 percent lower with the 60-mg dose, compared with placebo.

Viibryd Now Available in New Dose Strength

The Viibryd 20 mg therapeutic dose is now available in pharmacies Read More...

A new oral dosage strength was approved by the FDA on March 16 for Viibryd (vilazodone). Viibryd by Actavis is a dual-acting selective serotonin reuptake inhibitor and a 5-HT1A receptor partial agonist antidepressant indicated for the treatment of major depressive disorder (MDD). The FDA approved a lower 20 mg therapeutic dose of Viibryd (vilazodone) to accompany the 40 mg daily therapeutic dose. Viibryd was approved in January 2011 as a selective serotonin reuptake inhibitor (SSRI) and 5HT1a receptor partial agonist for the treatment of MDD in adults at a dose of 40 mg/day.

Antipsychotics in Dementia: More Dangerous Than Previously Thought

One-third of seniors with dementia in nursing homes in 2012 were prescribed antipsychotics, according to a federal government report Read More...

In 2005 the FDA issued a black-box warning of increased mortality risk with atypical antipsychotic use in elderly dementia patients. The use of antipsychotic drugs increases the risk of heart problems and premature death in people with dementia. Now, alarmingly, a new study published in JAMA Psychiatry suggests antipsychotic drugs may further increase the risk of premature death in dementia patients. For the new study, researchers examined data from 91,000 elderly U.S. veterans with dementia. Those who took antipsychotics were more likely to die early. Among those taking the newer atypical  antipsychotics, the risk of premature death was dose-related, too.