There are differing opinions on this. Here are three options that could happen --
1) FDA approves plazomicin for cUTI and BSI (CRE) simultaneously in June, no label. That would be the most optimal outcome.
2) FDA approves plazomicin for cUTI and BSI (CRE) simultaneously in June, however a warning label is placed for BSI by the FDA. That makes the most sense to me personally. Achaogen could eventually get this label taken off with more trials and data, but that would take time. In the mean time, physicians could use plazo in patients with no other alternatives.
3) FDA approves plazomicin for cUTI, rejects for BSI. That would be the bear case. Achaogen would be forced into more trials and money at this point.
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Here is the rub in all in of this -- plazomicin showed promise in patients with carbapenem-resistant Enterobacteriaceae (CRE) with better mortality rates than the current, clinical alternative which is colistin. That was the promise that this drug showed. There are not current alternatives. However, the committee got simply bogged into the details of how data for the study was collected and total patient number. This was not an easy trial to conduct. Imagine being on death's door with a bacterial infection that cannot be treated with available antibiotics. Those were the patients evaluated for plazomicin in BSI. In that short window, the patient had to be selected for the trial, get everything squared away to begin, and the required data collected including cultures pre- and post-treatment. It is just discouraging to me because we are running out of options to treat these multiple drug resistant bacteria, and what is in it for these companies that undertake the cost of these trials only to be held up on trivial things like how quickly a catheter was replaced? If there is so much risk and little money to be made, where will the innovation come from for new antibiotics? That, to me, is the killer in all of this.
Rant over. The FDA seems like they do want to approve, so we will wait to June. If you can take the short-term pain, wait til then and see what happens. If not, then get out quickly.