Alerts & Corrections

Erelzi (etanercept-szzs) Approved

FDA approves Erelzi, a biosimilar to Enbrel

AHFS Patient Medication Information Update – August 2016

The August update to the AHFS Patient Medication Information (PMI) database has been published. Highlights of the update include:

New PMI Monographs:

  • Obeticholic Acid (Ocaliva®)
    • Obeticholic acid is used alone or in combination with ursodiol (Actigall, Urso) to treat primary biliary cholangitis (PBC; a type of liver disease that destroys bile ducts, which allows bile to stay in the liver and cause damage) in patients who cannot take ursodiol or in patients who were not treated successfully with ursodiol alone.
  • Sofosbuvir and Velpatasvir (Epclusa®)
    • The combination of sofosbuvir and velpatasvir is used alone or with ribavirin (Copegus, Rebetol, Ribasphere) to treat chronic hepatitis C (an ongoing viral infection that damages the liver).
  • Atezolizumab Injection (Tecentriq®)
    • Atezolizumab injection is used to treat urothelial cancer (cancer of the lining of the bladder and other parts of the urinary tract) that has spread and cannot be removed by surgery, and has worsened after treatment with other chemotherapy medications.
  • Daclizumab Injection (Zinbryta®)
    • Daclizumab is used to prevent episodes of symptoms and slow the worsening of disability in people who have relapsing-remitting forms (course of disease where symptoms flare up from time to time) of multiple sclerosis (MS ; a disease in which the nerves do not function properly and people may experience weakness, numbness, loss of muscle coordination, and problems with vision, speech, and bladder control).

FDA MedWatch Alerts – Monograph Revisions

  • No MedWatch Alerts this month

Adlyxin (lixisenatide) Approved

FDA approves Adlyxin to treat type 2 diabetes

The U.S. Food and Drug Administration approved Adlyxin (lixisenatide), a once-daily injection to improve glycemic control (blood sugar levels), along with diet and exercise, in adults with type 2 diabetes.

“The FDA continues to support the development of new drug therapies for diabetes management,” said Mary Thanh Hai Parks, M.D., deputy director, Office of Drug Evaluation II in the FDA’s Center for Drug Evaluation and Research. “Adlyxin will add to the available treatment options to control blood sugar levels for those with type 2.”

Type 2 diabetes affects more than 29 million people and accounts for more than 90 percent of diabetes cases diagnosed in the United States. Over time, high blood sugar levels can increase the risk for serious complications, including heart disease, blindness and nerve and kidney damage.

Adlyxin is a glucagon-like peptide-1 (GLP-1) receptor agonist, a hormone that helps normalize blood sugar levels. The drug’s safety and effectiveness were evaluated in 10 clinical trials that enrolled 5,400 patients with type 2 diabetes. In these trials, Adlyxin was evaluated both as a standalone therapy and in combination with other FDA-approved diabetic medications, including metformin, sulfonylureas, pioglitazone and basal insulin. Use of Adlyxin improved hemoglobin A1c levels (a measure of blood sugar levels) in these trials.

In addition, more than 6,000 patients with type 2 diabetes at risk for atherosclerotic cardiovascular disease were treated with either Adlyxin or a placebo in a cardiovascular outcomes trial. Use of Adlyxin did not increase the risk of cardiovascular adverse events in these patients.

Adlyxin should not be used to treat people with type 1 diabetes or patients with increased ketones in their blood or urine (diabetic ketoacidosis).

The most common side effects associated with Adlyxin are nausea, vomiting, headache, diarrhea and dizziness. Hypoglycemia in patients treated with both Adlyxin and other antidiabetic drugs such as sulfonylurea and/or basal insulin is another common side effect. In addition, severe hypersensitivity reactions, includinganaphylaxis, were reported in clinical trials of Adlyxin.

The FDA is requiring the following post-marketing studies for Adlyxin:

  • Clinical studies to evaluate dosing, efficacy and safety in pediatric patients.
  • A study evaluating the immunogenicity of lixisenatide.

Adlyxin is manufactured by Sanofi-Aventis U.S. LLC, of Bridgewater, New Jersey.

The FDA, an agency within the U.S. Department of Health and Human Services, protects the public health by assuring the safety, effectiveness, security of human and veterinary drugs, vaccines and other biological products for human use, and medical devices. The agency is also responsible for the safety and security of our nation’s food supply, cosmetics, dietary supplements, products that give off electronic radiation, and for regulating tobacco products.

 

1 15 16 17 18 19 22