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Weekly Drug News Round Up - October 3, 2012

Stivarga Approved Under FDA Priority Review

Stivarga reviewed under program that provides an expedited six-month review for drugs that offer major advances in treatment Read More...

The U.S. Food and Drug Administration (FDA) has approved Stivarga (regorafenib), an oral multi-kinase inhibitor. Stivarga is the second new drug in two months that has been approved for the treatment of adults with metastatic colorectal cancer. In a randomized, controlled trial patients treated with Stivarga plus best supportive care (BSC) lived a median of 6.4 months compared to a median of five months in patients treated with placebo plus BSC. In August 2012, the FDA also approved Zaltrap (ziv-aflibercept) for use in combination with FOLFIRI (folinic acid, fluorouracil and irinotecan) chemotherapy regimen to treat metastatic colorectal cancer.

New Indication for Humira: Ulcerative Colitis

Humira indicated when agents such as corticosteroids, azathioprine, and 6-mercaptopurine have not worked Read More...

Ulcerative colitis leads to intestinal inflammation, rectal bleeding and diarrhea and affects roughly 620,000 Americans. The U.S. Food and Drug Administration (FDA) has approved Humira (adalimumab) for the treatment of moderate-to-severe ulcerative colitis. In placebo-controlled trials, 16.5 to 18.5 percent of patients treated with Humira achieved clinical remission compared with 9.2 to 9.3 percent of patients receiving placebo. Additionally, 8.5 percent of patients treated with Humira sustained their clinical remission. Humira is also approved for treatment of rheumatoid arthritis, plaque psoriasis, psoriatic arthritis, ankylosing spondylitis, Crohn’s disease and juvenile idiopathic arthritis.

FDA Approves Quillivant XR for Attention Deficient Hyperactivity Disorder

Quillivant XR is the first once daily, extended-release liquid methylphenidate available for ADHD Read More...

The U.S. Food and Drug Administration (FDA) has approved an extended-release, oral suspension form of methylphenidate hydrochloride (Quillivant XR) for the treatment of patients with Attention Deficit Hyperactivity Disorder (ADHD). The efficacy of Quillivant XR was evaluated in a multicenter study of 45 children with ADHD. Quillivant XR significantly improved ADHD symptoms compared to placebo four hours after the dose was given, and in a secondary analysis, at every time point measured, from 45 minutes to 12 hours after dosing. Quillivant XR may provide an advantage for patients who have difficulty swallowing pills or capsules and is expected to become available in pharmacies in January 2013.

Cholesterol-Lowering Statins May Reduce Glaucoma Risk

The mechanism of action may be that statins decrease eye pressure or increase blood flow to the eye Read More...

While aspirin might be dubbed the “Wonder Drug”, the cholesterol-lowering medications called “statins” seem to be running a close second. A review of medical records of more than 500,000 Americans over the age of 60 with high cholesterol found that those taking statins for one year had a four to five percent decreased risk of developing glaucoma compared to those not taking statins. Approved to treat high cholesterol, statins such as Lipitor (atorvastatin) and Zocor (simvastatin) have been studied for benefits in a number of conditions, including central nervous system disorders such as ischemic stroke, Alzheimer's and multiple sclerosis.

Beta Blockers May Not Be Cardioprotective: Study

Additional research is needed to identify subgroups that benefit from beta-blocker therapy and the optimal treatment periods Read More...

In an observational study published this week in Journal of the American Medical Association, researchers report that beta-blockers, such as propranolol, atenolol, or carvedilol may not prevent heart attack, stroke or death. The study involved 44,000 people with a history of heart attack, heart disease without heart attack, or risk factors for heart disease. For those with heart disease or who had previously suffered a heart attack, the researchers found no difference between those taking beta-blockers and those not taking them when it came to death, heart attack or stroke - among other findings.