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news.Tetraphase Pharmaceuticals has secured approval from the US Food and Drug Administration (FDA) for its Xerava (eravacycline) to treat complicated intra-abdominal infections (cIAI).
Image: Xerava packaging and product vial. Photo: courtesy of Tetraphase Pharmaceuticals.
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Xerava has been developed for the treatment of cIAI in patients 18 years of age and older.
In clinical trials, Xerava has showed statistical non-inferiority to two widely used comparators, including ertapenem and meropenem.
Intra-abdominal infection (IAI), which includes a wide variety of disease processes, is classified as uncomplicated or complicated based on the extent of the infection.
Xerava is a novel and fully-synthetic fluorocycline antibiotic to treat cIAI. It showed potent activity against MDR pathogens.
Xerava was studied in IGNITE (investigating gram-negative infections treated with eravacycline) phase 3 programs.
The twice-daily intravenous (IV) eravacycline achieved the primary endpoint in the first pivotal phase 3 trial in patients with cIAI. It showed statistical non-inferiority of clinical response compared to ertapenem and was well-tolerated.
The twice-daily IV eravacycline also reached met the primary endpoint in the second phase 3 clinical study. It showed statistical non-inferiority of clinical response compared to meropenem and was well-tolerated.
Xerava met high cure rates in patients with Gram-negative pathogens, including resistant isolates, in both studies.
Xerava has also secured positive opinion from the CHMP for cIAI, and is under review for marketing approval the European Commission to treat cIAI.
Tetraphase Pharmaceuticals president and CEO Guy Macdonald said: “The approval of XERAVA is an extraordinary achievement, one for which we thank the patients who have participated in our clinical studies, study investigators and physicians as well as our dedicated employees.
“We are thrilled to have received FDA approval, and a positive opinion from the Committee for Medicinal Products for Human Use (CHMP) in Europe all within the same quarter.”
Tetraphase has developed an advanced chemistry technology, which is being used to create novel antibiotics for serious and life-threatening bacterial infections.
The company has created over 3,000 novel tetracycline compounds by using its technology platform. Its pipeline is also comprised of TP-271 and TP-6076, which are currently under phase 1 clinical studies.
