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Weekly Drug News Round-Up: April 12, 2017

Ingrezza First Approved Treatment for Adults with Tardive Dyskinesia

Tardive dyskinesia is estimated to affect at least 500,000 people in the U.S Read More...

Tardive dyskinesia (TD) is characterized by uncontrollable, abnormal and repetitive movements of the trunk, extremities and/or face caused by dopamine blockade in the brain, such as occurs with antipsychotics. This week, the U.S. Food and Drug Administration (FDA) approved Neurocrine's Ingrezza (valbenazine) capsules for the treatment of adults with tardive dyskinesia. Ingrezza, a novel, highly selective vesicular monoamine transporter 2 (VMAT2) inhibitor, is the first product indicated for adults with TD. In studies, Ingrezza led to significant improvement in TD signs and symptoms compared to placebo through six weeks, with continued improvement through 48 weeks of treatment. Somnolence (drowsiness) was the most common side effect.

Harvoni and Sovaldi Both Approved for Pediatric HCV Population

There are roughly 23,000-46,000 pediatric HCV patients in the US, most of whom were infected with the virus at birth Read More…

The FDA has given the green light to both Harvoni (ledipasvir and sofosbuvir) and Sovaldi (sofosbuvir) for the treatment of chronic hepatitis C virus (HCV) infection in adolescents without cirrhosis or with compensated cirrhosis, 12 years of age and older, or weighing at least 35 kg (77 lbs). Sovaldi was approved for pediatric patients with genotype 2 or 3 chronic HCV infection, in combination with ribavirin, while Harvoni was approved for pediatric patients with genotype 1, 4, 5 or 6 chronic HCV infection. Harvoni is a once-daily NS5A inhibitor and nucleotide analog polymerase inhibitor and Sovaldi is a once-daily oral nucleotide analogue.

Beware of Fraudulent Products Claiming to Cure Autism: FDA

Speak with your doctor about scientifically proven treatments

There is no cure for autism spectrum disorder, a neurodevelopmental disorder that affects about 1 in 68 children in the US, more boys than girls. Today the FDA warned that bogus products - ranging from chelation therapies, hyperbaric oxygen therapy and detoxifying clay baths to raw camel milk - are making the rounds and being touted as a cure for autism. The FDA is warning consumers to be wary of products claiming multiple or miracle “cures”, as well as those said to offer a “quick fix” or that have “secret ingredients.” Consumers should check with their doctor before using any treatment, and ask if valid scientific evidences exists for the product.

FDA Allows Genetic Disease Test to Be Marketed

Knowing one’s genetic risk profile may aid in lifestyle choices or discussions with a health care professional Read More...

Have you ever wondered what your genes hold in store for you? This past week, the FDA allowed marketing of 23andMe Personal Genome Service Genetic Health Risk (GHR) tests for 10 diseases or conditions. These are the first tests that can be sold directly to consumers that provide information on one’s genetic predisposition to certain medical conditions, such as Parkinson’s disease, Alzheimer’s disease or celiac disease, a disorder resulting in the inability to digest gluten. However, genetic risk is just one piece of the puzzle: it does not mean you will definitely develop the disease. Environment and lifestyles can also increase the risk for certain diseases.

USPSTF Updates Recommendations for Prostate Cancer Screening

For men aged 70 and older, the recommendation for no PSA screening remains in place Read More...

The prostate-specific antigen (PSA) screening test is used for detecting prostate cancer. However, in 2012, the U.S. Preventive Services Task Force (USPSTF) recommended that men no longer have their PSA tested. That recommendation was based on evidence that PSA screening resulted in overdiagnosis and unnecessary treatment that could leave men impotent and incontinent. Now, after reviewing follow-up evidence, the task force is recommending in a draft publication that men aged 55 to 69 have a discussion with their doctor about the pros and cons of PSA screening to determine if it is an appropriate preventive test. For many men, prostate cancer is slow growing and takes many years to be life-threatening.