FDA again declines approval of Nabriva's antibiotic for urinary tract infections

Nabriva Therapeutics

20/06/2020 02:46

June 19 (Reuters) - The U.S. Food and Drug Administration
declined to approve Nabriva Therapeutics Plc's  NBRV.O 
antibiotic for complicated urinary tract infections, citing
still-unresolved manufacturing issues, the biopharmaceutical
company said on Friday.
    Nabriva said in a statement that the complete response
letter from the FDA for the resubmission of the new drug
application for Contepo, for injection, cited observations at
the company's manufacturing partners that could not be resolved
due to the FDA's inability to conduct onsite inspections because
of travel restrictions from the coronavirus outbreak.
    The FDA did not request any new clinical data and did not
raise any other concerns with regard to the safety or efficacy
of Contepo, Nabriva said.
    In April last year, the FDA had declined to approve
Nabriva's antibiotic, asking the company to address issues
relating to manufacturing deficiencies at one of its contract
manufacturers.  urn:newsml:reuters.com:*:nL1N22D01N
    "In general, previously identified product quality and
facility inspection related observations at our contract
manufacturing partners are required to be satisfactorily
resolved before the NDA (new drug application) may be approved,"
Nabriva said in the statement.
    Contepo, chemically known as fosfomycin, is the first
intravenously administered drug from a class of antibiotics
called epoxide in the United States.
    Fosfomycin was first discovered in 1969 and has been used to
treat a variety of serious bacterial infections including
complicated urinary tract infections in countries outside the
United States.
    The company said it plans to request a meeting with the FDA
to discuss the next steps and the FDA's plans for completing
foreign facility inspections.
    

 (Reporting by Kanishka Singh in Bengaluru; Editing by Leslie
Adler)
 ((Kanishka.Singh@thomsonreuters.com; +91 8061822801;))