Antibiotic Development: Limited Population Pathway In US Removes Barrier
Allergan's Avycaz could be indicator of how FDA will use the 21st Century Cure's new approval mechanism; experts maintain the provision does not lower FDA's standards of safety.
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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.
Achaogen can take solace in US FDA's approval of the aminoglycoside antibacterial for the treatment of complicated urinary tract infections, but the limited use indication for bloodstream infections was rejected.
Plazomicin's BSI Indication Gets 'No' From Advisory Panel, But US FDA Still Might Approve Under LPAD Pathway
Achaogen should at least be reassured by advisory committee's unanimous 'yes' vote for plazomicin's cUTI indication.