FDA Approves Antibacterial Drug for Complicated Urinary Tract Infections
Officials with the FDA have announced the approval of Vabomere (Rempex) for the treatment of complicated urinary tract infections (cUTI).
Officials with the FDA have announced the approval of Vabomere (Rempex) for the treatment of complicated urinary tract infections (cUTI). Vabomere is intended for adults with cUTI, including a type of kidney infection, pyelonephritis, caused by a specific bacteria.
Vabomere contains meropenem, an antibacterial and vaborbactam that inhibits certain types of resistance mechanisms used by bacteria.
The approval is based on a clinical trial including 545 adults with cUTI, including those with pyelonephritis, who were treated intravenously with Vabomere. At the end of treatment, approximately 98% of patients treated with Vabomere compared with approximately 94% of patients treated with piperacillin/tazobactam demonstrated improvement in symptoms and a negative urine culture test.
Seven days after completing the treatment, approximately 77% of those who were treated with Vabomere had resolved symptoms and a negative urine culture, compared to approximately 73% of patients treated with piperacillin/tazobactam.
The most common adverse effects of Vabomere were headache, site reactions, and diarrhea. It is also associated with serious risks including allergic reactions. Patients with a history of anaphylaxis should not take Vabomere.
Vabomere, which was designated as a qualified infectious disease product, should only be used to treat or prevent infections that are proven or strongly suspected to be caused by susceptible bacteria.
FDA approves new antibacterial drug [news release]. FDA’s website. https://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm573955.htm. Accessed August 30, 2017.