FDA Cites Travel Restrictions in CRL

Nabriva Therapeutics reports that FDA says travel restrictions are preventing the on-site inspection of a European contract manufacturer.

Nabriva Therapeutics, a Dublin, Ireland-based biopharmaceutical company, announced on June 19, 2020 that it received a complete response letter (CRL) from FDA noting the agency was not able to conduct on-site inspections at a contract manufacturing facility used by Nabriva due to pandemic-related travel restrictions.

The letter was in response to the company’s resubmission of a new drug application (NDA) seeking marketing approval of CONTEPO (fosfomycin) for injection for the treatment of complicated urinary tract infections (cUTI), including acute pyelonephritis.

On April 30, 2020, Nabriva reported that the company had received a CRL from FDA for its NDA seeking marketing approval of CONTEPO, citing issues related to facility inspections and manufacturing deficiencies at one of Nabriva’s contract manufacturers. At the time, Nabriva reported that the company planned to request a “Type A” meeting to discuss FDA’s findings. The agency did not request new clinical data and did not raise concerns about the safety of CONTEPO, Nabriva reported.

“Although Nabriva’s European contract manufacturing partners were prepared for regulatory authority inspections, the CRL cites observations at our manufacturing partners that could not be resolved due to FDA’s inability to conduct onsite inspections because of travel restrictions,” the company reported in a June 19, 2020 press statement. “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 may be approved.”

Nabriva said FDA did not request new clinical data or raise other concerns with regard to CONTEPO in the latest CRL. The company reported that it plans to meet with FDA to discuss the next steps and the agency’s plans for completing foreign facility inspections. 

Source: Nabriva Therapeutics