FDA News

Tetraphase announces FDA approval of Xerava for cIAIs

Photo of Larry Tsai
Larry Tsai

Tetraphase Pharmaceuticals announced that the FDA has approved Xerava for the treatment of complicated intra-abdominal infections, or cIAIs.

“As a physician, I am really excited about this approval of Xerava (eravacycline), because it means we have an important weapon in the fight against antibiotic resistance,” Larry Tsai, MD, chief medical officer of Tetraphase, told Infectious Disease News.

“Eravacycline was found to be well-tolerated with high clinical cure rates during clinical trials in patients with complicated intra-abdominal infections, when compared with treatment with ertapenem and meropenem,” Tsai said.

Eravacycline is indicated for treating cIAIs in patients aged 18 years and older, according to a news release. Tetraphase noted that to reduce the development of drug-resistant bacteria and to maintain the effectiveness of eravacycline, it should be used only to treat infections that are proven or strongly suspected to be caused by susceptible bacteria.

CIAI diagnoses include intra-abdominal abscess, stomach or intestinal perforation, peritonitis, appendicitis, cholecystitis and diverticulitis.

Tetraphase also noted that early detection, containment and appropriate treatment are essential when treating inter-abdominal infections.

“Early appropriate antibiotic coverage is critical because it has been shown that delays in antibiotics that are effective against specific bacteria causing infection result in worse outcomes,” Tsai said. “We need to choose the right empiric antibiotics. We need to make the best educated guess in treating patients with cIAI.”

The FDA approval was based on two phase 3 clinical trials that found that eravacycline, a fully synthetic fluorocycline, demonstrated statistical noninferiority to ertapenem and meropenem, both widely used carbapenems. Tsai noted that eravacycline was found to be highly effective, safe and well-tolerated in both studies.

 “Xerava provides an alternative to carbapenems and treats most of the bacteria that carbapenems treat,” Tsai said.

Tsai noted that because Xerava is from a completely different class of antibiotics, “when used appropriately, it will be less likely to select for bacteria that are resistant to carbapenems and to other classes of antibiotics.” Eravacycline is part of the tetracycline class of antibiotics. 

“At Tetraphase, through a new proprietary chemistry platform, we were able to breathe new life into this old class of antibiotics using wholly synthetic process,” he said.

“Infectious disease specialists want more choices, as far as new antibiotics,” Tsai added. “Xerava provides a good choice as an alternative to this last line of defense against antibiotic-resistant bacteria in carbapenems.”

Tetraphase said the commercial launch of eravacycline is expected in the fourth quarter of 2018. – by Bruce Thiel

Disclosure: Tsai is employed by Tetraphase Pharmaceuticals.

Photo of Larry Tsai
Larry Tsai

Tetraphase Pharmaceuticals announced that the FDA has approved Xerava for the treatment of complicated intra-abdominal infections, or cIAIs.

“As a physician, I am really excited about this approval of Xerava (eravacycline), because it means we have an important weapon in the fight against antibiotic resistance,” Larry Tsai, MD, chief medical officer of Tetraphase, told Infectious Disease News.

“Eravacycline was found to be well-tolerated with high clinical cure rates during clinical trials in patients with complicated intra-abdominal infections, when compared with treatment with ertapenem and meropenem,” Tsai said.

Eravacycline is indicated for treating cIAIs in patients aged 18 years and older, according to a news release. Tetraphase noted that to reduce the development of drug-resistant bacteria and to maintain the effectiveness of eravacycline, it should be used only to treat infections that are proven or strongly suspected to be caused by susceptible bacteria.

CIAI diagnoses include intra-abdominal abscess, stomach or intestinal perforation, peritonitis, appendicitis, cholecystitis and diverticulitis.

Tetraphase also noted that early detection, containment and appropriate treatment are essential when treating inter-abdominal infections.

“Early appropriate antibiotic coverage is critical because it has been shown that delays in antibiotics that are effective against specific bacteria causing infection result in worse outcomes,” Tsai said. “We need to choose the right empiric antibiotics. We need to make the best educated guess in treating patients with cIAI.”

The FDA approval was based on two phase 3 clinical trials that found that eravacycline, a fully synthetic fluorocycline, demonstrated statistical noninferiority to ertapenem and meropenem, both widely used carbapenems. Tsai noted that eravacycline was found to be highly effective, safe and well-tolerated in both studies.

 “Xerava provides an alternative to carbapenems and treats most of the bacteria that carbapenems treat,” Tsai said.

Tsai noted that because Xerava is from a completely different class of antibiotics, “when used appropriately, it will be less likely to select for bacteria that are resistant to carbapenems and to other classes of antibiotics.” Eravacycline is part of the tetracycline class of antibiotics. 

“At Tetraphase, through a new proprietary chemistry platform, we were able to breathe new life into this old class of antibiotics using wholly synthetic process,” he said.

“Infectious disease specialists want more choices, as far as new antibiotics,” Tsai added. “Xerava provides a good choice as an alternative to this last line of defense against antibiotic-resistant bacteria in carbapenems.”

Tetraphase said the commercial launch of eravacycline is expected in the fourth quarter of 2018. – by Bruce Thiel

Disclosure: Tsai is employed by Tetraphase Pharmaceuticals.