ID Pipeline News: Cefiderocol, IL-6 Diagnostics, & Imipenem-Cilastatin and Relebactam

The following is a roundup of the latest ID pipeline developments.

FDA Grants Cefiderocol Priority Review for New Indication

The US Food and Drug Administration’s (FDA) November 2019 approval of cefiderocol for the treatment of complicated urinary tract infections (cUTI) was one of the most notable infectious disease pipeline developments of the year.

Cefiderocol functions as a siderophore and has a novel mechanism of action which penetrates the outer cell membrane of Gram-negative pathogens.

Today, Shionogi announced that the FDA accepted a supplemental new drug application concerning use of cefiderocol in patients with hospital-acquired bacterial pneumonia (HABP) and ventilator-associated bacterial pneumonia (VABP). The FDA granted the drug priority review with a Prescription Drug User Fee Act (PDUFA) date of September 27, 2020.

The supplemental new drug application is based on results from the Phase III APEKS-NP study, in which cefiderocol met the primary endpoint of non-inferiority relative to high-dose extended-infusion meropenem in all-cause mortality in the treatment of patients with HABP, VABP and healthcare-associated bacterial pneumonia.

According to Shionogi’s press release, the antibiotic “demonstrated no unexpected safety signals; the incidence of treatment-emergent adverse events was similar between treatment arms.”

“We are committed to working with the FDA in order to bring FETROJA (cefiderocol) to more patients fighting these challenging and life-threatening Gram-negative infections as quickly as possible,” said Akira Kato, PhD, president and CEO of Shionogi. “This submission represents our heritage in and commitment to developing antimicrobial therapies and filling unmet needs in the field of infectious disease.”

APEKS-NP, which stands for Acinetobacter baumannii, Pseudomonas aeruginosa, Escherichia coli, Klebsiella pneumoniae and Stenotrophomonas maltophilia in Nosocomial Pneumonia, was designed to evaluate the efficacy and safety of cefiderocol for nosocomial pneumonia.

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FDA Authorizes IL-6 Test for Early Detection of Severe COVID-19 Illness

The US Food and Drug Administration (FDA) has issued an Emergency Use Authorisation (EUA) for the Elecsys IL-6 test, according to Roche. The test can be used on Roche’s “cobas e” analysers.

The test measures levels of interleukin 6 (IL-6) to identify patients with coronavirus disease 2019 (COVID-19) at high risk of intubation.

“The test can support physicians, in combination with other examinations and vital signs, to decide early on if a patient with confirmed COVID-19 illness requires mechanical ventilation,” Roche indicated in a press release.

The company noted that test results from this particular diagnostic take approximately 18 minutes, with a potential output of up to 300 tests per hour.

The immunoassay uses human serum or plasma. Under the EUA, the assay can be used to alongside clinical observation in identifying severe inflammatory response. IL-6 is released early during severe SARS-CoV-2 infection, and thus can identify severely ill patients as soon as possible.

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FDA Approves Imipenem-Cilastatin and Relebactam for HABP/VABP

The US Food and Drug Administration (FDA) has approved antibiotic combination imipenem-cilastatin and relebactam (Recarbrio) for the treatment of hospital-acquired bacterial pneumonia and ventilator-associated bacterial pneumonia (HABP/VABP) in patients aged 18 years and older.

The indication follows a previous FDA approval for the Merck antibiotic combination in treating patients with complicated urinary tract infections and complicated intra-abdominal infections.

Recarbrio’s efficacy and safety in treating HABP/VABP was evidenced in a randomized, controlled trial involving 535 adults hospitalized with HABP/VABP due to gram-negative bacteria.

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