Nabriva tanks on getting second CRL for Contepo

22 June 2020

Dublin, Ireland-based Nabriva Therapeutics (Nasdaq: NBRV) has revealed receiving a second Complete Response Letter (CRL) from the US Food and Drug Administration for the New Drug Application (NDA) resubmission seeking marketing approval of Contepo (fosfomycin) for injection for the treatment of complicated urinary tract infections (cUTI), including acute pyelonephritis.

In April 2019, the FDA issued a CRL noting that certain deficiencies with one of Nabriva’s contract manufacturers must be addressed. The latest news pushed the company’s shares down 32.2% to $0.56 in pre-market trading today.

Although Nabriva’s European contract manufacturing partners were prepared for regulatory authority inspections, the CRL cites observations at the manufacturing partners that could not be resolved due to FDA’s inability to conduct onsite inspections because of travel restrictions.

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