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FDA Approves Achaogen's Antibiotic For Urinary Tract Infection, But Issues CRL For Bloodstream Infections

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FDA Approves Achaogen's Antibiotic For Urinary Tract Infection, But Issues CRL For Bloodstream Infections

Achaogen Inc (NASDAQ: AKAO)'s tryst with the FDA regarding its anti-bacterial agent plazomicin, as expected, ended with a mixed outcome, just as the FDA panel issued a split verdict on it when it met in May.

The stock was down about 11 percent to $10.65 in pre-market trading.

What Happened

Achaogen announced Tuesday its Zemdri, the trade name for plazomicin, was greenlighted by the FDA for treating adults with complicated urinary tract infections including pyelonephritis, due to certain Enterobacteriaceae for which there's limited or no alternative treatment option.

However, the FDA issued complete response letter, or CRL, for plazomicin as a potential treatment option for blood stream infection, citing inadequate evidence of effectiveness thrown up by the CARE study, a Phase 3 trial that evaluated it for the indication.

Why It's Important

Zemdri is administered intravenously, as a once-a-daily dose. It has potent activity in difficult-to-treat multi-drug resistant infections, including carbapenem-resistant Enterobacteriaceae, or CRE, and ESBL-producing Enterobacteriaceae.

"Aminoglycosides are a familiar and very effective class of antibiotics. I look forward to adding plazomicin to my short list of available treatment options and to its potential impact on patient outcomes," said James A. McKinnell, Assistant Professor of Medicine at the David Geffen School of Medicine and LA Biomed at Harbor-UCLA.

What's Next

Achaogen said it will work with hospital, providers and insures to ensure the treatment option is available to patients.

Regarding BSI, Achaogen intends to meet with the FDA to explore whether any feasible solution exists for addressing the CRL.

Given the highly limited treatment options available for patients with BSI, SunTrust Robinson Humphrey analyst Edward Nash said in a May note that physicians may focus on the robust data from the CARE study and still prescribe it based on data, and not label, even if the FDA disapproves it for BSI.

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