Achaogen announced that an FDA advisory panel voted unanimously in favour of the safety and effectiveness of the company's experimental drug plazomicin for the treatment of complicated urinary tract infections (cUTI). However, on a second question regarding plazomicin's safety and effectiveness for the treatment of bloodstream infections in patients with limited or no treatment options, only four committee members offered their support for the therapy, with 11 voting against.
Shares in Achaogen, which is seeking approval of plazomicin for the treatment of cUTI, including pyelonephritis, and bloodstream infections due to certain Enterobacteriaceae in patients who have limited or no alternative treatment options, fell as much as 28 percent on the news. The FDA is scheduled to make a decision on approval of the drug by June 25.
Achaogen submitted the application seeking clearance of plazomicin in October last year, with the FDA accepting the filing earlier this year, granting it priority review. The company noted that the application is based on data from the Phase III EPIC and CARE studies, with the former trial showing that plazomicin was non-inferior compared to meropenem for the treatment of patients with cUTI and acute pyelonephritis. Meanwhile, in the CARE study, plazomicin demonstrated a 71-percent relative reduction in day 28 all-cause mortality compared with colistin in patients with bloodstream infections due to carbapenem-resistant Enterobacteriaceae.
The company is seeking approval of plazomicin for the treatment of bloodstream infections via the FDA's Limited Population Antibacterial Drug (LPAD) pathway, which allows the regulator to consider the benefits and risks for the sickest patients who have few or no available treatment options. However, due to the CARE trial enrolling less than 40 patients, Achaogen noted that "due to limitations of the small sample size, no formal statistical hypothesis testing was performed."
Commenting on the news, Acaogen CEO Blake Wise said "we are encouraged by the committee's unanimous vote in favour of plazomicin for complicated urinary tract infections." Blake added "the discussion underscored the real-world challenges that healthcare providers face every day given limited or inadequate treatment options for certain pathogens."
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