FDA rejects Nabriva’s antibiotic over manufacturing concerns
The FDA has rejected a proposed antibiotic from the Irish biotech Nabriva Therapeutics, citing concerns about manufacturing standards.
News of the rejection comes at a time when there is a pressing need for new antibiotics because of the rise of bacterial strains that are resistant to approved agents, some of which have been on the market for decades.
Nabriva was seeking a licence for Contepo (fosfomycin), an injection to treat complicated urinary tract infections, including pyelonephritis.
Although the drug has been approved for decades outside the US, the company hopes that its limited use in the country will mean resistant strains will be less likely to be encountered.
In a statement Nabriva said that FDA asked it to address issues that had been highlighted at inspections of manufacturing facilities, operated by one of the company’s contractors.
However the suggestion from the Dublin-based firm is that the regulator could approve the drug once the issues are resolved.
The company is planning a meeting to discuss the findings and noted that the regulator did not request new clinical data, or raise any concerns about Contepo’s safety.
Nabriva’s CEO Ted Schroeder said: “We will be working with the FDA in the coming weeks to gain a full understanding of the FDA’s comments, with the goal of bringing this important treatment to patients as quickly as possible.”
Contepo, previously referred to as ZTI-01 and Zolyd in the US, is a potential first-in-class antibiotic in the US.
It is active against a broad spectrum of Gram-negative and Gram-positive bacteria, including most contemporary multi-drug resistant strains.
The drug has been approved outside of the US in a number of indications for more than 45 years outside the US to treat a variety of injections.
Nabriva added that the dosing approach will optimise the pharmacokinetic and pharmacodynamic properties of the compound.
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