August 2015, Vol 3, No 8 - Inside Products and Services

New Drugs/Devices

The following are recent approvals announced by the US Food and Drug Administration (FDA):

  • Entresto (sacubitril/valsartan) tablets were approved for the treatment of patients with heart failure. Side effects reported by clinical trial participants included hypotension, hyperkalemia, and renal impairment; angioedema was also reported. This medication should not be used with any other angiotensin-converting enzyme (ACE) inhibitors, and the drugs should be separated by 36 hours when switching between Entresto and an ACE inhibitor.
  • Praluent (alirocumab) has been approved for use in patients with heterozygous familial hypercholesterolemia or with clinical atherosclerotic cardiovascular disease. Praluent is the first cholesterol-lowering treatment approved in the new class of proprotein convertase subtilisin/kexin type 9 inhibitors.
  • Technivie (ombitasvir, paritaprevir, and ritonavir) was approved in combination with ribavirin for the treatment of patients with hepatitis C genotype 4 infections without scarring or poor liver function. The drug carries a warning acknowledging that liver enzymes were elevated to >5 times the upper limit in approximately 1% of the clinical trial participants.
  • Daklinza (daclatasvir) was approved in combination with sofosbuvir for the treatment of patients with hepatitis C genotype 3 infections. It is the first drug with demonstrated safety and efficacy for the treatment of this type of infection without the coadministration of interferon or ribavirin.
  • Odomzo (sonidegib), a new treatment option for patients with locally advanced basal-cell carcinoma, has been approved by the FDA in patients with a recurrence after surgery or radiation therapy, or in patients who are not candidates for surgery or radiation therapy.
  • Bio-Rad BioPlex 2200 HIV Ag-Ab assay is the first diagnostic test that is FDA approved to differentiate between the different types of human immunodeficiency virus (HIV) infections in adults, in children aged ≥2 years old, and in pregnant women.
  • Rexulti (brexpiprazole) was approved for the treatment of adults with schizophrenia and adults with major depressive disorder as an add-on treatment to an antidepressant. The most common side effects reported were weight gain and an inner sense of restlessness.
  • Iressa (gefitinib), a kinase inhibitor that blocks proteins that promote the development of cancer cells with certain epidermal growth factor receptor (EGFR) mutations, was approved as a first-line treatment in patients with metastatic non–small-cell lung cancer, including tumor cells with the exon 19 deletions or exon 21 L858R substitution gene mutations, as detected by the FDA-approved therascreen EGFR RGQ PCR Kit.
  • The ReShape Integrated Dual Balloon System (ReShape Dual Balloon) was approved as a nonsurgical temporary device for weight reduction in obese adults with a body mass index of 30 kg/m2 to 40 kg/m2; with 1 or more obesity-related conditions, including high blood pressure, high cholesterol, and diabetes; and who are unable to achieve weight loss using diet and exercise alone.



US Food and Drug Administration. Press announcements. www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/default.htm. Updated July 15, 2015. Accessed July 30, 2015.

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