FDA approves new products

The Food and Drug Administration has approved the HPV vaccine Gardasil 9 for people between the ages of 27 and 45.  The vaccine protects against human papillomavirus, which can lead to cervical cancer in women and throat cancer in men.   Prior to Friday’s announcement, the vaccine was only approved for younger ages, beginning at age 9 until the age of 26.  Health officials had recommended that children receive the shot before they become sexually active.

“Today’s approval represents an important opportunity to help prevent HPV-related diseases and cancers in a broader age range,” Dr. Peter Marks, director of the FDA’s Center for Biologics Evaluation and Research, said in a statement.  In a study of 3,200 women between the ages of 27 through 45, the vaccine was 88 percent effective in preventing infection, genital warts, and cervical cancer.  Side effects included some pain in the area the shot was administered, as well as swelling, redness, and headaches.  HPV is one of the most common types of sexually transmitted diseases, infecting about 14 million people in the U. S. every year.

In other action, the FDA approved the final Opioid Analgeic Risk Evaluation and Mitigation Strategy (REMS).  This REMS now includes immediate-release opioid analgesics used in outpatient settings as well as the extended-release and long-acting opioid analgesics that have already been subject to a REMS since 2012.  Under this REMS, training must be made available to all health professionals, including pharmacists and nurses, who provide care for patients who have pain, and the education must offer broader information about pain management, such as alternatives to opioids.

FDA has had a busy 2018 on the biosimilar front, approving three products last spring and summer: poetin alpha-epbx (Retacrit-Pfizer) in May, pegfilgrastim-jmbd (Fulphila-Mylan) in June, and filgrastim-aafi (Nivestym-Pfizer) in July, bringing the total number of biosimilars currently approved in the United States to 12.  Of the 12 biosimilars currently approved, only four are currently available.