Shionogi celebrates antibiotic win in pneumonia just ahead of its date with FDA regulators
Just weeks before Shionogi is scheduled to hear back from the FDA on treating complicated urinary tract infections with its antibiotic, the Japanese pharma has another slate of positive data on a different indication to share.
Investigators laid out the full numbers on cefiderocol in adults with nosocomial pneumonia caused by gram-negative pathogens — a particularly tough to beat condition for hospitalized patients, given its multiple resistance mechanisms. In a Phase III, the drug appeared non-inferior to high-dose meropenem in all-cause mortality after two weeks of treatment.
At that time point, 12.4% of the modified intent-to-treat population who received cefiderocol (18/145) died, compared to 11.6% in the meropenem group (17/146). In a smaller subset of patients who are microbiologically evaluable, ACM was 12.4% for cefiderocol and 13% for meropenem.
“In this trial, nearly 60 percent of patients were ventilated and approximately 33 percent experienced treatment failure of prior therapy,” said Shionogi CMO Tsutae “Den” Nagata. “Recently, several new antibiotics have been introduced to address some carbapenem-resistant infections, but they do not address all resistant Gram-negative pathogens. Clinicians are in urgent need of novel therapeutic approaches to overcome the multiple resistance mechanisms that make these strains so difficult to treat.”
A member of the cephalosporin class, cefiderocol is designed to bind to ferric iron, thereby sneaking through the outer membrane of bacterial cells via the iron transporters and punching holes.
The drug has been designated as a qualified infectious disease product (QIDP) by the FDA, with a PDUFA date on November 14, 2019. In its latest pipeline roundup, the company noted that cefiderocol is being positioned for cUTIs in the US and a much broader label — namely multidrug-resistant gram-negative bacterial infections — in Europe. Though it had initially been accepted into the EMA’s accelerated approval program, CHMP regulators pulled it out of that track in July.
With nosocomial pneumonia, Shionogi was taking on a tough disease that recently tripped up Polyphor due to concerns about acute kidney injury on its drug — the latest cautionary tale in a failure-ridden antibiotics world.
Social image: Shionogi, Hiromitsu Morimoto via flickr