Glass half empty: Achaogen receives split vote from FDA experts on lead antibiotic, shares plunge
An FDA advisory committee has handed down a split vote — yes for one indication and no for another — on Achaogen’s lead antibiotic, ruffling the high expectations it set up going in.
Investors weren’t happy, sending Achaogen stocks down close to 29% in after-hours trading.
The split decision carries interesting implications for other antibiotic makers. In a first, Achaogen $AKAO submitted an NDA with a request to use the Limited Population Antibacterial Drug (LPAD) pathway in reviewing the drug, plazomicin, for the treatment of bloodstream infections (BSI) due to Carbapenem-resistant Enterobacteriaceae. That happens to be the indication that the adcomm voted down; all 15 of them voted yes when it came to treating patients with complicated urinary tract infections (cUTI).
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