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Weekly Drug News Round Up - March 11, 2015

FDA Approves First Biosimilar Product Zarxio

A biosimilar must have no clinically meaningful differences in terms of safety and effectiveness Read More…

On Friday, March 6th the U.S. Food and Drug Administration (FDA) approved Sandoz’s Zarxio (filgrastim-sndz), the first U.S. approved biosimilar. Zarxio, the biosimilar for Amgen’s filgrastim (Neupogen), is a recombinant granulocyte colony-stimulating factor used to boost white blood cells after cancer treatments. Biological products are generally derived from a living organism, including humans, animals, microorganisms or yeast. According to the RAND Corporation, biosimilars could save the U.S. health system close to $44 billion in the next ten years. Other top biologics facing future patent expiration include Humira (2018), Enbrel (2015), and Avastin (2019), all well-known brands in the U.S.

Cresemba Wins FDA-Approval for Rare Fungal Infections

Cresemba is the sixth product designated as a Qualified Infectious Disease Product (QIDP) Read More...

The U.S. Food and Drug Administration (FDA) has approved Astellas Pharma’s Cresemba (isavuconazonium sulfate), an azole antifungal for use in adults with invasive aspergillosis and invasive mucormycosis, both considered rare but serious fungal infections in the blood. These infections occur most often in people with weakened immune systems. The FDA approved Cresemba under a priority review. It may be given as capsules or through an IV placed in the arm (intravenously). Serious side effects reported with Cresemba are liver toxicity, drug interactions (including ones with cyclosporine, sirolimus, or tacrolimus), infusion reactions, and severe allergic reactions.

Unituxin Approved as First Treatment for High-Risk Neuroblastoma

In clinical trials, patients were 11 months to 15 years of age, with a median age of 3.8 years Read More...

FDA has approved Unituxin (dinutuximab), a GD2-binding chimeric monoclonal antibody as part of treatment for pediatric patients with high-risk neuroblastoma. Unituxin is to be used in combination with granulocyte-macrophage colony-stimulating factor (GM-CSF), interleukin-2 (IL-2), and 13-cis-retinoic acid (RA) in children who achieve at least a partial response to prior first-line therapy. In clinical trials, 226 patients were randomized to six cycles of either the dinutuximab/RA arm or the RA alone arm. The dinutuximab/RA arm consisted of dinutuximab plus either GM-CSF, RA, and/or IL-2. At analysis, the median event-free survival (EFS) was not reached (3.4 years) in the dinutuximab/RA arm and was 1.9 years (1.3) in the RA arm.

FDA Drug Safety Update: Possible Chantix-Alcohol Interaction

Patients should decrease alcohol consumption until they know how Chantix will affect them Read More...

Chantix (varenicline) is a medication used for smoking cessation in adults. FDA is now warning that Chantix may alter how people react to alcohol, including increased intoxication that may be associated with aggressive behavior and/or amnesia (loss of memory) and rare seizure activity. The Chantix prescription label will be updated to reflect these risks. Patients who have a seizure while taking Chantix should stop the medicine and seek medical attention immediately. Providers should weigh the benefit versus the possible harm of Chantix use in patients at risk for seizures, and should communicate to patients that Chantix should be stopped if changes in behavior or suicidal ideation develop.

Statins Linked to Elevated Risk for Type 2 Diabetes: Study

Type 2 diabetes occurs when the body becomes resistant to insulin, needed to process food sugars Read More...

An additional study reports that the use of HMG Co-A reductase inhibitors, known commonly as statins, may elevate the risk for developing type 2 diabetes. Researchers in Finland tracked the effects of statin treatment in almost 9,000 men without diabetes over the course of six years. One in four men were on statins. According to researchers, 625 men were newly diagnosed with type 2 diabetes, and those treated with statins were 46 percent more likely to develop diabetes than those not treated with statins. The diabetes risk increased with the dosage taken of the statin drugs simvastatin (Zocor) and atorvastatin (Lipitor).