The ID Pipeline: FDA Activity From the Week of February 23, 2020

Here is a look at infectious disease-related US Food and Drug Administration (FDA) news from the week of February 23, 2020.

Positive Results for Cefepime-Enmetazobactam in Phase 3 Trial

More than 100 million people around the world are impacted by complicated urinary tract infections each year, leading to sizable social costs and health burden on patients. Additionally, the global rise of antimicrobial resistance among gram-negative pathogens is a concerning problem suggesting the need for new treatment options.

Allecra Therapeutics has announced that its investigational antibiotic combination cefepime-enmetazobactam met the European Medicines Agency and US Food and Drug Administration (FDA) pre-specified primary endpoint in the phase 3 ALLIUM clinical trial.

The combination features enmetazobactam, a novel extended-spectrum β-lactamase inhibitor, and cefepime, a fourth-generation cephalosporin.

Read the full article here.

Cefiderocol Available for Treatment of cUTI in the US

Shionogi & Co. have announced that Cefiderocol, approved in November 2019, is now available in the United States for patients 18 years or older with limited or no alternative treatment options for the treatment of complicated urinary tract infections caused by Gram-negative microorganisms.

The approval of Cefiderocol was one of the more notable drug approvals of 2019 due to a mix of positive and negative study results presented to the FDA in the leadup to the drug’s approval. The availability of the drug will now allow clinicians to work out the role of the drug in a real world setting.

Read the press release.

FDA Grants Breakthrough Therapy Designation to Exebacase MRSA Bacteremia Treatment

Contrafect Corporation has announced that their Exebacase treatment for methicillin-resistant Staphylococcus aureus (MRSA) bacteremia has been granted Breakthrough Therapy designation.

Breakthrough Therapy designation allows the FDA to expedite the development and review of medicines for life-threatening diseases with preliminary clinical evidence that the investigational therapy may provide substantial improvements over available therapies.

Read the press release.