Plazomicin's BSI Indication Gets 'No' From Advisory Panel, But US FDA Still Might Approve Under LPAD Pathway
Executive SummaryAchaogen should at least be reassured by advisory committee's unanimous 'yes' vote for plazomicin's cUTI indication.
You may also be interested in...
Clinicians and sponsors want the US FDA to open up antibacterial labeling to include more data on efficacy against resistant pathogens and in other body sites, but regulatory restrictions may require a workaround in the form of rapid, peer-to-peer communications about the data on new products.
Amikacin liposome inhalation suspension for the treatment of Mycobacterium avium complex lung disease is first antimicrobial approved under 21st Century Cures Act pathway; LPAD designation request appears to have occurred after an advisory committee recommended approval for more limited population than requested by Insmed.