New Antibiotics for Europe: CHMP Likes Vabomere, EC Clears Xerava

Megan Brooks

Disclosures

September 21, 2018

The European Medicines Agency's (EMA) Committee for Medicinal Products for Human Use (CHMP) has recommended approval of the antibiotic Vabomere (Rempex London) to treat various infections in adults.

Vabomere combines the carbapenem antibacterial meropenem with vaborbactam, which inhibits certain types of bacterial resistance mechanisms.

CHMP recommended Vabomere for treatment of complicated intra-abdominal infections (cIAIs) and complicated urinary tract infections (cUTIs), hospital-acquired pneumonia, bacteremia that occurs in association with any of these infections, and infections because of aerobic Gram-negative organisms where treatment options are limited.

"The lack of availability of medicines to treat patients with infections caused by resistant bacteria has become a major problem in recent years. It is estimated that at least 25,000 patients in the European Union die each year from infections due to bacteria that are resistant to many medicines," the EMA said in a statement.

Vabomere will be available as a powder for concentrate for solution for infusion.

"Vabomere, through its antibacterial action, has been shown to be effective at treating the above-mentioned infections. The most common side effects are headache, diarrhea, infusion site phlebitis, and nausea," the EMA said. 

The US Food and Drug Administration (FDA) cleared Vabomere in August.

EC Clears Eravacycline (Xerava)

In related news, the European Commission (EC) has granted marketing clearance for the antibacterial eravacycline (Xerava, Tetraphase Pharmaceuticals) for treatment of cIAIs in adults in the European Union.

Eravacycline is a novel fully synthetic fluorocycline antibiotic that belongs to the tetracycline group of antibiotics. In clinical trials, eravacycline was well-tolerated and achieved high clinical cure rates in patients with cIAI, demonstrating statistical noninferiority to ertapenem and meropenem, the company said in a news release.

The EC approval of eravacycline follows a positive opinion issued by CHMP in July, as reported by Medscape Medical News.

The FDA cleared eravacyline in August.

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