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Weekly Drug News Round-Up: July 19, 2017

FDA Approves Gilead’s Vosevi for Six Hepatitis C Genotypes

Vosevi is a fixed-dose, once-daily combination tablet with the new drug voxilaprevir, a pangenotypic NS3/4A protease inhibitor Read More...

The U.S. Food and Drug Administration (FDA) has approved Gilead’s Vosevi (sofosbuvir, velpatasvir and voxilaprevir) for retreatment of adults with chronic hepatitis C virus (HCV) of two types: either genotype 1, 2, 3, 4, 5, or 6 previously treated with an NS5A inhibitor regimen, or genotype 1a or 4 previously treated with a sofosbuvir regimen without an NS5A inhibitor. Vosevi is used in patients without cirrhosis (liver disease) or with compensated cirrhosis who were not successfully treated with other HCV drugs. In studies, 96 to 97 percent of patients who received Vosevi had no virus detected 12 weeks after finishing treatment, suggesting that infections were cured. Common side effects include headache, fatigue, diarrhea, and nausea.

Nerlynx Cleared To Lower Risk of Breast Cancer Recurrence

Roughly 15 percent of patients with breast cancer have tumors that are HER2-positive Read More...

The FDA has approved Puma Biotechnology’s Nerlynx (neratinib), a once-daily oral tyrosine kinase inhibitor for the extended adjuvant treatment of early stage HER2-positive breast cancer, following adjuvant trastuzumab (Herceptin) based therapy. Nerlynx is the first extended adjuvant therapy to further lower this type of breast cancer recurrence. In clinical studies after two years, 94.2% of patients treated with Nerlynx had not experienced cancer recurrence or death compared with 91.9% percent of patients receiving placebo. Common side effects include diarrhea, nausea, abdominal pain, fatigue, and vomiting, among others. Patients should be given loperamide for the first 56 days of treatment, then as needed, to help manage diarrhea.

Janssen’s Tremfya Gains Approval for Treatment of Plaque Psoriasis

Tremfya is a first-in-class biologic that blocks IL-23, a cytokine that plays a key role in plaque psoriasis Read More...

Janssen’s Tremfya (guselkumab), an interleukin-23 blocker, has been FDA-approved to be used in adults with moderate-to-severe plaque psoriasis who are candidates for systemic therapy or phototherapy. Tremfya is given as a 100 mg subcutaneous injection. In clinical studies, patients receiving Tremfya experienced significant improvement in skin clearance and greater improvement in itching, pain, stinging, burning and skin tightness when compared with placebo at week 16. Superior results in skin clearance compared with Humira (adalimumab) were shown at weeks 16, 24 and 48. Common side effects may include respiratory infections, headache, injection site reactions, and joint pain, among others.

Alzheimer's Researchers Hunting for Much-Needed Treatments

A new drug for Alzheimer's hasn't been approved in the United States since 2003 Read More...

Alzheimer’s disease is catching up to us. About 5.5 million Americans currently have Alzheimer's disease. But by 2050, the number of cases in the United States could be as high as 16 million, according to the Alzheimer's Association. The good news? Research for new treatments is active. Studies include 27 drugs in phase 3 clinical trials, which are in the last phase of drug research prior to FDA submission. Also, there are eight drugs in phase 2 clinical trials, according to investigators. And nearly three dozen new Alzheimer's drugs may begin clinical trials in the next five years.

Over 80 Million Americans Have Prediabetes: CDC

With exercise and a healthy diet, prediabetics can halve their risk of developing type 2 diabetes Read More...

A new report released Tuesday from the U.S. Centers for Disease Control and Prevention (CDC) denotes that as of 2015, more than 9 percent of the population -- 30.3 million -- had diabetes. Another 84.1 million had prediabetes. People with prediabetes have elevated blood sugar levels, but not so high that they have full-blown type 2 diabetes, which requires diabetes medication or insulin injections. However, awareness is low: nearly 1 in 4 adults with diabetes didn't know they had diabetes, and less than 12 percent knew they had prediabetes. If not treated, prediabetes often leads to type 2 diabetes within five years. Bottom line: talk to your doctor about your blood sugar levels and take action, if needed.