The Food and Drug Administration (FDA) announced that it has approved three new drugs in recent months for the purpose of fighting acute bacterial skin and skin structure infections (ABSSSI) caused by antibiotic-resistant bacteria like methicillin-resistant Staphylococcus aureus, better known as MRSA.
The new antibiotic approvals fall in line with the President’s executive order and national strategy for Combating Antibiotic Resistant Bacteria (CARB), according to a blog post issued on the FDA’s site. The FDA blog post stated that the Generating Antibiotics Incentives Now Act (GAIN Act), the Antibacterial Drug Development Task Force, and multiple guidance documents are all part of a greater strategy to combat antibiotic resistant bacteria, after the announcement by the WHO that we are entering into a post-antibiotic era.
The FDA highlighted the three antibiotics that have been approved this year.
“On May 23, FDA approved Dalvance (dalbavancin), an injectable drug, administered intravenously in two doses one week apart.”
“On June 20, FDA approved Sivextro (tedizolid phosphate), available for intravenous and oral use, administered once daily for six days.”
“On August 6, FDA approved Orbactiv (oritavancin), an injectable drug administered as a single dose to comprise a full course of therapy.”
According to the FDA, all three drugs were approved after being designated as a Qualified Infectious Disease Product (QIDP) under the GAIN Act. Because each was designated as a QIDP, each antibiotic’s approval was expedited through the FDA approval process.
One of the benefits of qualifying as a QIDP for the manufacturer of the antibiotic is that each of these antibiotics was granted marketing exclusivity. According to the FDA, 39 antibiotics have been granted the QIDP designation, making their development worth their manufacturers’ investment.
“We still have a long way to go in getting a leg up on building a new and more effective arsenal of antimicrobial products. And once approved, it will be critical for health care professionals to appropriately prescribe these new antibiotics,” Janet Woodcock, M.D., Director of FDA’s Center for Drug Evaluation and Research, explained. “But with ongoing collaborative, concerted efforts by the many public and private stakeholders, we can continue to advance and help build a national antibacterial research and development enterprise capable of bringing new drugs to the patients who need them. These three approvals are an encouraging start!”
Michael Smith, North American Correspondent for MedPage Today, stated that new antibiotics are often tested and approved for skin infections first because there are other avenues physicians can take if the condition is limited to a skin infection in the event that a new FDA-approved treatment or antibiotic fails.
[Photo via FDA]