U.S. FDA declines to approve Spero's urinary tract infection drug (updated)

Spero Therapeutics

27/06/2022 21:27

(Adds background, details of CRL)
    June 27 (Reuters) - The U.S. Food and Drug Administration
(FDA) declined to approve Spero Therapeutics Inc's  SPRO.O  oral
antibiotic drug for the treatment of patients with complicated
urinary tract infections, the company said on Monday. 
    In the complete response letter, the health regulator
concluded that Spero's late-stage study testing the drug was
insufficient and an additional study would be required, the
drugmaker said. 
    Shares of Spero fell about 14% after the bell. 
    Spero had sought approval for its most advanced drug
candidate, tebipenem, to treat the infections, including a type
of kidney inflammation called pyelonephritis in adult patients
with limited oral treatment options.
    But the company suffered a setback in March when the agency
found certain deficiencies in the drug's marketing application.
Spero later suspended commercialization activities for tebipenem
and slashed its workforce by about 75%, as the FDA's feedback
suggested that the data on the drug could be insufficient to
obtain approval.  urn:newsml:reuters.com:*:nL3N2WV1VL
    The drugmaker said on Monday it intends to promptly request
a meeting with the health regulator. 
    

 (Reporting by Amruta Khandekar and Bhanvi Satija; Editing by
Shounak Dasgupta and Aditya Soni)
 ((Amruta.Khandekar@thomsonreuters.com))