FDA says ‘threat of AMR’ behind Merck antibiotic label expansion

By Ben Hargreaves contact

- Last updated on GMT

(Image: Getty/Sudok1)
(Image: Getty/Sudok1)

Related tags: Fda, Merck, Zerbaxa, Cubist Pharmaceuticals

The US FDA approves Merck’s application to expand the label of Zerbaxa for the treatment of hospital-acquired infections to address ‘global challenge’ of AMR.

Zerbaxa (ceftolozane and tazobactam) was previously approved by the US Food and Drug Administration (FDA) for the treatment of complicated intra-abdominal infections and for complicated urinary tract infections.

Yesterday, the FDA added hospital-acquired bacterial pneumonia and ventilator-associated bacterial pneumonia (HABP/VABP) to the antibiotic’s label.

“A key global challenge we face as a public health agency is addressing the threat of antimicrobial-resistant (AMR) infections,”​ said FDA principal deputy commissioner, Amy Abernethy.

Abernethy added that HABP/VABP can result in an increased likelihood of death, and developing new therapies to treat such infections is particularly necessary given the rise of AMR.

In its release regarding the approval, Merck, known as MSD outside of the US and Canada, stated that the treatment “should be used only to treat or prevent infections that are proven or strongly suspected to be caused by susceptible bacteria.”

It is hoped that this action will reduce the development of drug-resistant bacteria.

Merck received priority review designation to speed up the application process for the antibacterial treatment. The company acquired the drug as part of its $9.5bn (€8.45bn) of Cubist Pharmaceuticals​.

The priority review was received under the FDA’s qualified infectious disease product designation, which is intended to speed up the review of antibacterial or antifungal drug products for serious or life-threatening conditions.

The need to speed up the review of such products arrives after a number of the larger pharma companies​ have pulled out or reduced investment in the space – despite it being considered one of the biggest threats to global health​ by the World Health Organization (WHO).

More measures are being applied by regulatory authorities​ to improve the development of such medicines, with smaller companies taking advantage of bigger companies’ exit to embark on early-stage R&D​.

Related topics: Markets & Regulations, Regulations

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