FDA News

FDA approves Zemdri to treat cUTIs, but not bloodstream infection

Achaogen, Inc. announced that the FDA has approved plazomicin for the treatment of complicated urinary tract infections, or cUTIs, but not bloodstream infections, or BSIs.

Zemdri (plazomicin) is a once-daily aminoglycoside with microbiological activity against gram-negative pathogens, including carbapenem-resistant Enterobacteriaceae and extended-spectrum beta-lactamase-producing Enterobacteriaceae. It is administered once daily as an IV infusion.

Achaogen submitted a new drug application (NDA) for plazomicin to treat cUTIs and BSIs and had been granted a priority review by the FDA. The NDA was based on data from the phase 3 EPIC and CARE clinical trials.

Based on data from the EPIC trial, the FDA approved the antibiotic to treat cUTIs, including pyelonephritis, caused by certain Enterobacteriaceae in adult patients who have limited or no alternative treatment options.

But Achaogen said the FDA issued a Complete Response Letter (CRL) stating that data from the CARE trial “does not provide substantial evidence of effectiveness of plazomicin for the treatment of BSIs.” Achaogen said it would meet with the FDA to address the CRL.

"The approval of Zemdri marks a significant milestone for Achaogen and we are excited to offer health care practitioners a new treatment option for patients with certain serious bacterial infections,” Achaogen CEO Blake Wise said in a statement. "This marks an important step in our commitment to fighting [multidrug-resistant] bacteria."

Reference:

Achaogen news release: http://investors.achaogen.com/releasedetail.cfm?ReleaseID=1070946.

Disclosures: Wise is the CEO of Achaogen.

Achaogen, Inc. announced that the FDA has approved plazomicin for the treatment of complicated urinary tract infections, or cUTIs, but not bloodstream infections, or BSIs.

Zemdri (plazomicin) is a once-daily aminoglycoside with microbiological activity against gram-negative pathogens, including carbapenem-resistant Enterobacteriaceae and extended-spectrum beta-lactamase-producing Enterobacteriaceae. It is administered once daily as an IV infusion.

Achaogen submitted a new drug application (NDA) for plazomicin to treat cUTIs and BSIs and had been granted a priority review by the FDA. The NDA was based on data from the phase 3 EPIC and CARE clinical trials.

Based on data from the EPIC trial, the FDA approved the antibiotic to treat cUTIs, including pyelonephritis, caused by certain Enterobacteriaceae in adult patients who have limited or no alternative treatment options.

But Achaogen said the FDA issued a Complete Response Letter (CRL) stating that data from the CARE trial “does not provide substantial evidence of effectiveness of plazomicin for the treatment of BSIs.” Achaogen said it would meet with the FDA to address the CRL.

"The approval of Zemdri marks a significant milestone for Achaogen and we are excited to offer health care practitioners a new treatment option for patients with certain serious bacterial infections,” Achaogen CEO Blake Wise said in a statement. "This marks an important step in our commitment to fighting [multidrug-resistant] bacteria."

Reference:

Achaogen news release: http://investors.achaogen.com/releasedetail.cfm?ReleaseID=1070946.

Disclosures: Wise is the CEO of Achaogen.