02 May 2019
Posted in Press Release
FDA hits Contepo with a complete response letter, but Nabriva’s pathway to antibiotics licensure is still open, says GlobalData
Following the FDA issue of a complete response letter (CRL) on April 30, 2019 for Nabriva Therapeutics’ Contepo for the treatment of complicated urinary tract infections (cUTIs),
Paul Jeng, Senior Pharma Analyst at GlobalData, a leading data and analytics company, offers his view on the expectations for Nabriva in the coming months:
”Although the CRL slams the brakes on Contepo’s immediate commercial prospects in the US, it is likely that Nabriva will be successful in addressing the FDA’s manufacturing concerns, given that no additional clinical data was requested.
”If the drug is eventually approved, it will be critical for Nabriva to compensate for its delay in revenue by actively seeking label expansions for Contepo in the US market, including as combination therapy for multi-drug resistant infections. Contepo has the advantage of a relatively favorable adverse event profile, reinforced by the lack of safety concerns raised in the CRL.
”Recently, numerous funding incentive models have been proposed to stimulate a stagnant global antibiotics market, but the success of antibiotics developers still relies heavily on sales volume.
”Nabriva is also awaiting the FDA decision for a second experimental antibiotic, lefamulin, for treatment of community-acquired bacterial pneumonia (CABP). If both products reach the market, a key challenge for Nabriva will be balancing sales volume with antimicrobial stewardship programs aiming to curb the development of drug-resistant infections.”