Ireland-based Nabriva had its hopes raised when the FDA accelerated the PDUFA date of the biotech’s new antibiotic by two months. Those hopes were dashed with a cold splash of regulatory action when the drug was rejected because of problems with a contract manufacturer in Europe.
Nabriva announced that it received an FDA complete response letter for its new drug application for Contempo, its injected form of fosfomycin for the treatment of complicated urinary tract infections. The biotech said the FDA told it before approval it must address issues at its contract manufacturer related to facility inspections and manufacturing deficiencies.
In a call with investors, CEO Ted Schroeder would not identify the firm but said it was a contractor in Europe that was to supply product for that market and the rest of the world outside of North America. He said the company has yet to debrief with the manufacturer and will seek a Type A meeting with the FDA and the contractor to get to the heart of the issues.
“We don't know if this is specific to Contempo or some general manufacturing practices,” Schroeder told analysts.
He said the CDMO has so far not received a warning letter and even recently passed an inspection by European regulators without any observations.
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The CEO said depending on how the FDA tags the meeting, it will be two to six months before executives get to meet with FDA officials. Time is of the essence, however, because Nabriva has a second PDUFA date in August for another new antibiotic. Its drug candidate lefamulin would be the first pleuromutilin antibiotic for intravenous and oral administration in humans.
The stumbling block Nabriva faces with Contempo is not uncommon. In 2017, a warning letter for Pfizer’s Hospira plant in McPherson, Kansas, was responsible for derailing the expected approval of the long-lasting generic version of Teva’s Copaxone, developed jointly by Momenta and Sandoz. The companies received a complete response letter for Glatopa because of the problems at the Kansas plant that was handling the fill-finish work for the drug. The issues were finally resolved enough for the drug to gain approval, but by then a competing product had already been approved.