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Weekly Drug News Round Up - October 1, 2014

Two Gilead HIV Treatments Are FDA-Approved

Both drugs already found in approved HIV combo product Stribild Read More...

The U.S. Food and Drug Administration (FDA) has approved a pair of HIV drugs from Gilead. Vitekta (elvitegravir) is an integrase inhibitor for the treatment of HIV-1 infection in treatment-experienced adults. Viteka is one of the ingredients in the once-daily combination HIV drug Stribild, approved by the FDA in 2012. Tybost (cobicistat) is a potent cytochrome P450 3A enzyme inhibitor that acts as a "boosting" agent for HIV antiviral drugs. Tybost is used in combination with atazanavir or darunavir for the treatment of human immunodeficiency virus type 1 (HIV-1) infection. Cobicistat is also found in Stribild.

Iluvien Implant Gains FDA Approval for Diabetic Macular Edema

Iluvien is expected to be commercially available in early 2015 Read More...

The U.S. Food and Drug Administration (FDA) has approved Iluvien (fluocinolone acetonide intravitreal implant) 0.19 mg, a sustained release intravitreal implant used treat diabetic macular edema (DME). Iluvien is indicated in patients who have been previously treated with a course of corticosteroids and did not have a clinically significant rise in intraocular pressure. Each Iluvien implant is designed to release continuous delivery of the corticosteroid fluocinolone acetonide (FAc) for 36 months. FDA approval was based on studies that showed that at month 24, over 28 percent of patients receiving Iluvien experienced an improvement from baseline in their best-corrected visual acuity test.

AbbVie’s Humira Wins Approval for Pediatric Crohn's Disease

Children with moderate to severe Crohn’s disease have limited treatment options Read More...

Crohn's disease, a type of inflammatory bowel disease (IBD), is most often diagnosed in adolescents and young adults between 15 and 35 years of age. The U.S. Food and Drug Administration (FDA) has approved Humira (adalimumab) in pediatric Crohn's disease patients 6 years of age and older who have had an inadequate response to corticosteroids or immunomodulators such as azathioprine, 6-mercaptopurine, or methotrexate. Humira is the first approval for children that can be self-administered at home. Humira has been approved since 2012 by the European Commission for the treatment of Crohn’s disease in pediatric patients 6 to 17 years of age.

NSAIDS Recently Associated with Clot Risks

The study showed an association but it did not prove cause-and-effect Read More...

A new study published in Rheumatology has found an association between the use of NSAIDs like ibuprofen (Advil, Motrin) or naproxen (Aleve) and an 80 percent higher risk for venous thromboembolism (VTE). VTE includes potentially deadly clots like deep vein thrombosis (a leg clot) and pulmonary embolism (a lung clot). The results are not surprising as Vioxx, another powerful NSAID painkiller, was withdrawn from the market in 2004 after studies found a higher risk of heart attack and stroke in users. Aspirin, however, has sufficient blood thinning power to be used successfully to prevent clots.

FDA: Xolair Rx Label Updated With New Warnings

Patients should continue taking Xolair as prescribed and speak with their doctor about concerns Read More...

Xolair (omalizumab) is used in patients with allergic asthma who are not well-controlled on inhaled corticosteroids. The U.S. Food and Drug Administration (FDA) has alerted providers and patients of Xolair studies that suggest a slight risk of problems involving the heart and blood vessels supplying the brain. In addition, although the review found no difference in cancer rates between those patients being treated with Xolair and those who were not, due to study limitations, the FDA cannot rule out a risk. Therefore, these new warnings are now reflected in the Xolair labeling.