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Weekly Drug News Round-Up: November 16, 2016

Opdivo Approval Based on Overall Survival in Head and Neck Cancer

More than 50% of squamous cell head and neck cancer patients present with Stage III or higher disease Read More...

The U.S. Food and Drug Administration (FDA) has approved Bristol-Myers Squibb's Opdivo (nivolumab) injection to treat advanced squamous cell cancer of the head and neck that has progressed on or after a platinum-based therapy. Opdivo is the first immuno-oncology drug shown in a Phase 3 trial to extended overall survival (OS) in these patients. In the CheckMate-141 trial, the median OS was 7.5 months for Opdivo compared to 5.1 months for methotrexate, docetaxel or cetuximab. Opdivo can be associated with immune-mediated side effects, including inflammations of the lung, colon, liver, and kidney.

Gilead’s Vemlidy Cleared for Chronic Hepatitis B Virus Infection

Chronic hepatitis B is a life-threatening illness that affects up to 2.2 million people in the U.S. Read More...

Vemlidy (tenofovir alafenamide, TAF) 25 mg has been FDA-approved as a once-daily treatment for adults with chronic hepatitis B virus (HBV) infection with compensated liver disease. Vemlidy is an HBV nucleoside analog reverse transcriptase inhibitor and a tenofovir prodrug with similar antiviral effectiveness. However, due to a lower dose resulting in less tenofovir in the bloodstream, Vemlidy has improved kidney and bone laboratory safety parameters compared to Viread (tenofovir disoproxil fumarate, TDF). Vemlidy labeling contains a boxed warning regarding lactic acidosis/severe hepatomegaly with steatosis and post-treatment severe acute exacerbation of hepatitis B.

Selzentry Approved for Younger HIV Population

It is estimated that 2,037 people 19 years of age and younger became infected with HIV in 2014 Read More...

ViiV Healthcare has received FDA approval to market Selzentry (maraviroc) for the treatment of only CCR5-tropic HIV-1 infection, in combination with other antiretroviral agents, in patients 2 years of age or older who weigh at least 10 kilograms. Selzentry is not recommended in patients with dual/mixed- or CXCR4-tropic HIV-1. A new 25 mg and 75 mg tablet and a 20 mg per milliliter oral solution will be available in January 2017. Pediatric dosing is based on body surface area and potential drug interactions with potent cytochrome P450 3A inhibitors and/or inducers. Common side effects included vomiting (12%), abdominal pain (4%), diarrhea (4%), and dizziness (3%).

Essure Permanent Birth Control System: FDA Label Changes

Essure prevents conception by blocking the fallopian tubes with metallic coils, and is not intended to be removed Read More...

Essure is a long-term implantable birth control device FDA-approved in 2002. Essure labeling now includes a boxed warning and Patient Decision Checklist to help women understand the benefits and risks of permanent birth control devices like Essure. Some women who use Essure have reported serious complications such as prolonged pain, heavier menstrual cycles, allergic-type reactions, autoimmune-type reactions like joint pain and fatigue, which may result in the need for surgical removal. The FDA continues to advise women to review benefits and risks associated with permanent birth control devices with their doctors and understand the new checklists. Essure is not immediately effective in preventing pregnancy.

Atrial Fibrillation Patients Missing Out on Blood Thinners: But Why?

Researchers said these patients had a stroke risk score of 2 or higher, making them candidates blood thinners Read More...

As reported by researchers from Duke University, close to half of patients with atrial fibrillation who potentially could benefit from a blood thinner to help prevent blood clots and stroke are not receiving them. Researchers reviewed 1.6 million U.S. hospital admissions from a five year period and found that only 46% of patients received blood thinners at discharge. Possible reasons for low use include: need for education, concerns about using the drugs, and the belief that blood thinners should be started as an outpatient, rather than an inpatient, treatment. Blood thinners used to prevent blood clots in atrial fibrillation often include Eliquis (apixaban), Pradaxa (dabigatran), Savaysa (edoxaban), warfarin, or Xarelto (rivaroxaban).