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Tetraphase submits NDA for IV eravacycline to treat cIAIs
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Tetraphase Pharmaceuticals announced that it has submitted a new drug application to the FDA for IV eravacycline to treat complicated intra-abdominal infections, or cIAIs.
The company said in a news release that the NDA is supported by positive data from two phase 3 clinical trials, IGNITE1 and IGNITE4. Tetraphase president and CEO Guy Macdonald called the filing a “critical milestone” for the company.
“We believe that eravacycline has the potential to play a key role in the treatment of serious hospital infections, particularly gram-negative infections,” Macdonald said in the release. “We are now one step closer to realizing the goal of bringing this medicine to the market."
According to Tetraphase, eravacycline is a novel, fully synthetic fluorocycline antibiotic that is being developed for the treatment of serious infections, including those caused by multidrug-resistant (MDR) pathogens.
Findings from the IGNITE1 trial showed the drug was noninferior to ertapenem in the treatment of patients with cIAIs. Data from the IGNITE4 trial announced last summer demonstrated that eravacycline was noninferior to meropenem and achieved high clinical cure rates in patients with cIAIs.
According to Tetraphase, eravacycline has demonstrated potent activity against MDR pathogens like carbapenem-resistant Enterobacteriaceae, Acinetobacter baumannii and bacteria carrying the mcr-1 gene, which confers resistance to colistin. The drug is also in phase 3 clinical development for the treatment of complicated urinary tract infections.
Disclosure: Macdonald is the president and CEO of Tetraphase Pharmaceuticals.