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Weekly Drug News Round Up - October 2, 2013

Brintellix Approved for Major Depression

Episodes of depression often recur throughout a person's lifetime, although some may experience only a single occurrence Read More...

The U.S. Food and Drug Administration (FDA) has approved Brintellix (vortioxetine) to treat adults with major depressive disorder (MDD). Brintellix’s proposed mechanism of action is inhibition of serotonin (5-HT) reuptake. Brintellix is also an agonist at 5-HT1A receptors, a partial agonist at 5-HT1B receptors and an antagonist at 5-HT3, 5-HT1D and 5-HT7 receptors. Brintellix was shown effective compared to placebo in six adult MDD clinical trials, and an additional study that showed Brintellix decreased the likelihood of depression recurrence. More than 7,500 total patients aged 18 to 88 years old were enrolled in clinical trials. The most common side effects included nausea, constipation and vomiting.

Perjeta Gains New Use for Early-Stage Breast Cancer

Perjeta was previously approved for late-stage breast cancer in 2012 Read More...

The anti-cancer drug Perjeta (pertuzumab) has been approved by the U.S. Food and Drug Administration (FDA) to treat early-stage breast cancer before surgery. Perjeta is approved for use in patients with HER-2 positive early-stage breast cancer who are at increased risk of the cancer returning, spreading or of dying from the disease. The drug is to be used in combination with chemotherapy before surgery. Perjeta's safety and effectiveness were evaluated in a clinical study involving 417 people. The results from a confirmatory study in over 4,800 people are in process with results expected in 2016. In September, the FDA advisory panel voted 13 to 0 to recommend FDA approval of the drug.

Cimzia Approved for Psoriatic Arthritis

Up to 30 percent of the estimated 7.5 million psoriasis patients in the U.S. will develop active psoriatic arthritis Read More...

The U.S. Food and Drug Administration (FDA) has approved Cimzia (certolizumab pegol) for the treatment of adult patients with active psoriatic arthritis (PsA). PsA is a chronic, inflammatory condition that causes pain, swelling and stiffness in and around the joints and tendons, and usually occurs in combination with psoriasis. Cimzia is also approved for rheumatoid arthritis, Crohn’s disease and is currently undergoing FDA review for spondyloarthritis. In Phase 3 trials, Cimzia ACR20 response rates at weeks 12 and 24 were higher for each Cimzia dose group relative to placebo. Cimzia also led to psoriasis skin improvement in patients with PsA.

FDA Boxed Warning: Death Risk Increased with Tygacil

Tygacil is not indicated for treatment of diabetic foot infection or for hospital-acquired or ventilator-associated pneumonia Read More...

Tygacil (tigecycline) is an antibiotic approved to treat complicated skin and intra-abdominal infections and community-acquired bacterial pneumonia. The U.S. Food and Drug Administration (FDA) has issued a boxed warning for intravenous Tygacil detailing an increased risk of death. FDA analysis showed a higher risk of death among patients receiving Tygacil for FDA-approved uses compared to other antibacterial drugs: 2.5% (66/2640) vs. 1.8% (48/2628), respectively. In general, the deaths resulted from worsening infections, complications of infection, or other underlying medical conditions. FDA issued a previous Drug Safety Communication about this safety concern in September 2010.

Johns Hopkins Research Finds Memory Problems Not a Risk with Statins

In 2012, the FDA warned that some statin users had reported problems such as memory loss, forgetfulness and confusion Read More...

A new review suggests that statins may actually lower the risk of dementia, although the findings are not conclusive. This new data contradicts the approved package label for statins, the cholesterol-lowering drugs used by millions to prevent heart disease and stroke. At issue are the well-known medications such as Zocor (simvastatin), Crestor (rosuvastatin) and Lipitor (atorvastatin). Five of eight studies involving patients who took the drugs for at least a year found that they actually had lower risks of dementia.