FDA rejects Nabriva a second time; Nabriva pins it on travel restrictions
A little over a year after the FDA issued Nabriva its first CRL for the antibiotic Contepo, the agency has issued another.
By Nabriva’s account, the agency’s reasoning hasn’t changed. They again cited unresolved manufacturing issues at the company’s CMO facilities in Europe and asked for no new clinical data. The problem, Nabriva said, was that because of travel restrictions, the agency wasn’t able to do an onsite inspection of the facilities to confirm that the issues raised last year had been fixed.
Because neither companies nor the FDA release CRLs, it’s impossible to confirm the claim, but it wouldn’t be the first time travel restrictions have appeared to interfere with the review process. The agency warned in May that review times could be delayed. And earlier this month, Novartis announced that the decision date on its MS drug Arzerra had been pushed from June to September. Though the company didn’t specify reasons for the delay, one investor at their Q1 call noted possible outstanding manufacturing issues in Europe that Covid-19 could have made difficult to resolve.
The rejection is a blow to a company that, like other antibiotic makers, has already been ailing for some time. Although the Irish biotech reached $12 a share in 2017 off of positive Phase III results for the lead antibiotic and although that drug would soon be approved, their shares tumbled as other successful antibiotic makers filed for bankruptcy and investors began to realize the grim financial logic of antibiotics: To prevent resistance, you give new drugs only as a last resort; a new drug, however promising, can become fatally low-volume.
The latest rejection cut shares by 15% pre-market, but it had already entered penny-stock territory.
The drug, known chemically as fosfomycin, has been available in many countries outside the US since the early 1970s. Though often given orally, Nabriva had submitted an intravenous formulation for approval in complicated urinary tract infections. The company acquired it from Zavante in 2018 for 8.2 million shares — at the time worth around $25 million — and $100 million in milestones.