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Weekly Drug News Round-Up: July 6, 2016

FDA Approves Humira for Certain Forms of Uveitis

Humira is the first FDA-approved non-corticosteroid treatment option for certain types of uveitis Read More…

Humira (adalimumab) has received its 10th approved indication from the US Food and Drug Administration (FDA) to treat non-infectious intermediate, posterior and panuveitis. Uveitis is an inflammation of the uveal tract in the eye which includes the iris, ciliary body, and choroid. Humira targets and helps block TNF-alpha, a specific source of inflammation that can have a role in uveitis. In studies, patients treated with Humira had a significantly lower risk for treatment failure, defined as a combination of uveitic flare and decrease in visual acuity, compared to placebo. No new safety risks were identified.

Syndros Wins FDA Approval For Two Indications

Once Syndros has been opened, it does not need to be refrigerated for 28 days Read More...

The FDA has cleared Syndros (dronabinol), an oral solution of the cannabinoid dronabinol and a synthetic version of THC found in marijuana. Syndros is approved for use in treating anorexia associated with weight loss in patients with AIDS, and nausea and vomiting associated with cancer chemotherapy in patients who have failed to respond adequately to conventional antiemetic treatments. The liquid formulation will allow easier titration. Syndros is currently awaiting controlled substance scheduling by the DEA and it should be commercially available in the second half of 2016.

Genetic Cholesterol Disorder Boosts Risk for Serious Heart Disease

Heterozygous familial hypercholesterolemia affects about 1.5 million people in the U.S. Read More...

Heterozygous familial hypercholesterolemia (HeFH) is an inherited condition in which the genes prevent the liver from removing LDL (low-density lipoprotein) cholesterol from the blood. According to a new study published in Circulation, patients with familial hypercholesterolemia (above 190 mg/dL) had a five times higher risk for heart disease than people with average LDL cholesterol levels (less than 130 mg/dL). Plus, the research revealed earlier heart diseases with this condition, up to 20 years earlier in men and 30 years earlier in women. Drug treatment for HeFH includes the statins such as Lipitor (atorvastatin) and Crestor (rosuvastatin) and the newer PCSK9 inhibitors Praluent (alirocumab) and Repatha (evolocumab).

A Mom's Flu Shot During Pregnancy Important for Newborn

Current vaccines aren't approved for use in infants under 6 months of age Read More...

In the U.S., it won’t be long until the flu (influenza) vaccines are available. Many experts have emphasized the importance of flu vaccine protection to protect pregnant women and their newborns. According to the Centers for Disease Control and Protection (CDC), vaccination during pregnancy will confer some flu antibodies that will help to protect newborns from flu for up to 6 months after birth. However, a new study in JAMA Pediatrics showed that the vaccine’s effectiveness in infants was highest (85.6%) during the first eight weeks after birth, but does drop off to roughly 25-30% from 8 to 24 weeks of age. The authors conclude that there is a need to find more immunogenic vaccines for pregnant women.

HPV Vaccine Study Points To Cancer Prevention Promise

Canadian school-based vaccine program gave the three dose HPV vaccine targeting two common viral strains Read More...

A new Canadian study suggests that early treatment with the human papillomavirus (HPV) vaccine can prevent abnormalities that can lead to cervical cancer. In 2008, Alberta introduced HPV vaccination for school-aged girls 10 to 11 years, and a catch up program for girls age 14 to 15. Eight years later, researchers looked at Pap test results taken between 2012 and 2015 for more than 10,000 women between 18 and 21 years old. They found more than 16 percent of unvaccinated women had high-grade cervical abnormalities on a Pap test. However, in women who had been fully vaccinated, the rate of cervical abnormalities was 12 percent.