FDA Gives Thumbs Up to New Antibiotic

(RxWiki News) The US Food and Drug Administration (FDA) has approved a new antibiotic.

This new medication is found under the brand name Vabomere. It consists of two medications: meropenem and vaborbactam.

The FDA approved Vabomere to treat adults with complicated urinary tract infections (cUTIs), including the kidney infection pyelonephritis.

This medication is available as an injection to be administered into the vein.

A clinical trial that included 545 adults assessed Vabomere’s safety and effectiveness. At the end of treatment for cUTIs, 98 percent of patients who were given Vabomere were cured or saw an improvement in symptoms and received a negative urine culture test. And seven days after completing treatment, the portion of patients who had resolved symptoms and a negative urine culture test was at 77 percent.

Side effects of Vabomere may include headache, infusion-site reactions and diarrhea.

This medication is tied to some serious risks, such as allergic reactions and seizures. Vabomere should not be given to those who have a history of anaphylaxis, a type of severe allergic reaction to beta-lactams.

The FDA granted approval of Vabomere to Rempex Pharmaceuticals.