Annals of Long Term Care

FDA News

FDA Approves Use of Prevnar 13 Vaccine in Older Adults

On December 30, 2011, the FDA expanded the use of Prevnar 13, a pneumococcal 13-valent conjugate vaccine, to include people 50 years and older. Prevnar 13 prevents against pneumonia and invasive disease caused by Streptococcus pneumoniae. Prevnar 13 was previously approved for use in children between 6 weeks and 5 years of age to protect against invasive disease caused by 13 different serotypes of the bacterium.

According to the FDA press statement, approximately 300,000 adults 50 years and older are hospitalized each year because of pneumococcal pneumonia. “Pneumococcal disease is a substantial cause of illness and death. Today’s approval provides an additional vaccine for preventing pneumococcal pneumonia and invasive disease in this age group,” said Karen Midthun, MD, director, FDA Center for Biologics Evaluation and Research, in an FDA press statement.

The new use for Prevnar 13 was approved under the agency’s accelerated approval pathway, which enables earlier approval of treatments for serious and life-threatening illnesses. The pathway enables effectiveness of a vaccine to be demonstrated using an immune marker that is reasonably likely to predict clinical benefit. Accelerated approval is granted on the condition that a clinical trial is conducted during the post-approval marketing of the vaccine to verify the anticipated clinical benefit. Currently, an additional trial in 85,000 people aged 65 years and older is under way to confirm Prevnar 13’s efficacy in preventing pneumococcal pneumonia. For more information on Prevnar 13, including full prescribing information, visit www.prevnar13.com.

FDA Approves Generic Version of Lipitor

On November 30, 2011, the FDA granted approval to Ranbaxy Pharmaceuticals, Inc, and Watson Pharmaceuticals, Inc, to manufacture and market the first generic version of the cholesterol-lowering drug Lipitor (atorvastatin calcium tablets). The companies were approved to manufacture the drug in 10-mg, 20-mg, 40-mg, and 80-mg doses.

Approximately 8.7 million people in the United States take Lipitor. “The medication is widely used by people who must manage their high cholesterol over time, so it is important to have affordable treatment options,” said Janet Woodcock, MD, director, FDA Center for Drug Evaluation and Research, in an FDA press statement.

In combination with a low-fat diet and exercise, atorvastatin lowers low-density lipoprotein cholesterol and triglyceride levels in the body by blocking HMG CoA reductase, an enzyme in the liver that is responsible for cholesterol production. The drug has also shown to raise high-density lipoprotein levels, helping to prevent cholesterol from building up in the arteries. Atorvastatin reduces the risk of myocardial infarction, stroke, and angina in patients who have heart disease, risk factors for heart disease, or have undergone certain types of cardiac surgery. In clinical trials for Lipitor, the most common reported adverse events were inflammation of the nasal passages, joint pain, diarrhea, and urinary tract infections.