The federal agency gave the nod to Meitheal Pharmaceuticals for its antibiotic, Contepo, an intravenous fosfomycin offering a new mechanism of action and a new option for adults with complicated urinary tract infections, including those caused by resistant gram-negative pathogens.
The US Food and Drug Administration approved fosfomycin (Contepo), which is indicated for the treatment of adult patients with complicated urinary tract infections (cUTIs)—including acute pyelonephritis—caused by susceptible strains of Escherichia coli and Klebsiella pneumoniae. The antibiotic is manufactured by Meitheal Pharmaceuticals.
“The escalating public health issue of antimicrobial resistance and emergence of highly resistant organisms demands immediate attention and innovative therapeutic solutions. The approval of Contepo is a major milestone in our company’s evolution and the fight against the ongoing threat of antibiotic resistance,” Meitheal Pharmaceuticals CEO Tom Shea said in a statement.
The approval is backed by results from the pivotal phase 2/3 ZEUS trial, which evaluated the safety and efficacy of intravenous (IV) fosfomycin in hospitalized patients with cUTI, including pyelonephritis. In the microbiological modified intent-to-treat population, IV fosfomycin demonstrated noninferiority to piperacillin/tazobactam for the primary end point of overall success, defined as both clinical cure and microbiologic eradication.
Overall success was achieved in 63.5% of patients receiving fosfomycin compared with 55.6% receiving piperacillin/tazobactam. The therapy was generally well tolerated, with adverse reactions occurring in 2% or more of patients including transaminase elevations, hypokalemia, neutropenia, nausea, and electrolyte abnormalities.
Contepo offers a novel mechanism of action with no known cross-resistance, addressing rising challenges in antimicrobial resistance.
FDA approval is supported by Phase 2/3 trial data showing noninferiority to piperacillin/tazobactam for overall clinical and microbiologic success.
The approval strengthens Meitheal’s growing anti-infectives portfolio and meets a significant need for new options to treat the millions of cUTIs seen in hospitals annually.
This antibiotic belongs to a unique epoxide class, with no known cross-resistance to other antibiotic families. Its mechanism of action targets bacterial cell wall synthesis at an earlier stage than β-lactams, blocking the first committed step and disrupting all downstream processes essential for bacterial survival. This activity has shown effectiveness against gram-negative pathogens commonly implicated in cUTIs.
With an estimated 3 million cases of cUTIs treated in US hospitals each year, clinicians and public health officials have sought new therapies capable of overcoming growing resistance trends. Meitheal Chief Medical Officer Keith Robinson, MD, MS, FCCP, stated that the drug’s safety, efficacy, and novel mechanism of action position it as a valuable new option for patients with severe infections.
The approval also accelerates Meitheal’s commercial expansion. The company now offers more than 70 on-market products, with additional generic launches planned across key therapeutic areas including anti-infectives, anesthetics, critical care, fertility, and oncology.
