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Monthly News Roundup - June 2016

Epclusa: First Approval For All Major Forms of Chronic Hepatitis C Virus

The U.S. Food and Drug Administration (FDA) has given the go-ahead to Epclusa (sofosbuvir and velpatasvir), a nucleotide analog polymerase inhibitor and pan-genotypic NS5A inhibitor fixed-dose combination for the treatment of chronic hepatitis C virus (HCV) infection in adults. Epclusa is used for HCV genotypes 1 through 6, with or without cirrhosis. In studies, 95 to 99 percent of Epclusa-treated patients without cirrhosis or with mild cirrhosis had no virus detected 12 weeks after finishing the 3 month regimen. In patients with moderate to severe cirrhosis, some of whom required ribavirin, 94 percent were cleared of the virus 12 weeks after finishing treatment.

Vaxchora Gains FDA Clearance to Prevent Cholera in Travelers

Vaxchora (cholera vaccine, live, oral) is a vaccine indicated for active immunization against disease caused by Vibrio cholerae serogroup O1 in adults traveling to cholera-affected areas, such as Africa, Asia, India, and Mexico. Cholera, which can be rapidly fatal and requires treatment with fluids and antibiotics, is acquired by ingesting contaminated water or food and causes a watery diarrhea. In studies, Vaxchora was 90 percent effective among those challenged with the bacteria 10 days after vaccination and 80 percent among those challenged 3 months after vaccination. Common side effects include tiredness, headache, abdominal pain, nausea/vomiting, lack of appetite and diarrhea.

Fixed-Dose Combination Byvalson Gains Approval for Hypertension

The FDA has approved Allergan’s Byvalson (nebivolol and valsartan), the first beta adrenergic blocker and angiotensin II receptor blocker (ARB) fixed-dose combination indicated for the treatment of hypertension (high blood pressure) in the U.S. In pivotal studies published in The Lancet with 4,100 randomized patients with Stage 1 or 2 hypertension, treatment with the fixed-dose combo of nebivolol and valsartan for 4 weeks led to statistically significant reductions in blood pressure versus either nebivolol alone or valsartan alone. Byvalson will be available in 5 mg/80 mg tablets and Allergan expects it to be available commercially in the second half of 2016.

FDA Approves Zinbryta for Multiple Sclerosis

Multiple sclerosis, a chronic, inflammatory, autoimmune disease of the central nervous system, has been reported as the leading cause of disability in young adults 20 to 40 years of age. The FDA has now approved AbbVie/Biogen’s Zinbryta (daclizumab) for the treatment of adults with relapsing forms of multiple sclerosis (MS). Zinbryta, a humanized monoclonal antibody, is a long-acting injection that is self- administered by the patient monthly. In studies, patients using Zinbryta had fewer clinical relapses than patients taking placebo or Avonex (interferon beta-1a). A boxed warning alerts prescribers that Zinbryta can cause severe liver injury.

Probuphine Implant Approved for Treatment of Opioid Dependence

As an added weapon in the treatment of opiate addiction, the FDA has approved Probuphine, the first buprenorphine implant for the maintenance treatment of opioid dependence. Probuphine consists of four, one-inch-long rods that are implanted under the skin and provide a constant, low-level dose of buprenorphine for six months. In studies, 63 percent of Probuphine-treated patients had no evidence of illicit opioid use throughout the six months of treatment – similar to the 64 percent of those who responded to sublingual (under the tongue) buprenorphine alone.

Posted: June 2016