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FDA Updates Labeling on Janssen’s Doribax

March 10, 2014

The FDA has approved updated labeling for Janssen’s antibiotic Doribax after a study found that the drug caused an increased risk of death and lower clinical cure rates than a fixed course of imipenem and cilastatin in patients with ventilator-associated pneumonia (VAP).

The prospective, randomized, double-blind multicenter Phase III trial evaluated the noninferiority of Doribax (doripenem) as an investigational treatment in 524 patients hospitalized for at least five days with VAP. The trial was halted in 2011, after an interim analysis of 274 patients showed a 23 percent mortality rate in patients treated with Doribax, compared to a 16.7 percent rate in the imipenem-cilastatin arm. Patients treated with Doribax also showed 45.6 percent clinical cure rates, while patients treated with Primaxin showed 56.8 percent rates.

Based on this information, Doribax’s labeling will now note those risks, the FDA says, as well as a warning that the drug is not approved to treat VAP. The drug is still considered safe and effective for its approved indications — adults with complicated intra-abdominal infections and complicated urinary tract infections, including kidney infections.

Janssen originally attempted to gain FDA approval for a VAP indication for Doribax in 2008, but was met with a complete response letter. — Lena Freund

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