USFDA declines to approve Nabriva's antibiotic Contepo for urinary tract infections

The U.S. Food and Drug Administration on Tuesday declined to approve Nabriva Therapeutics Plc's antibiotic Contepo for complicated urinary tract infections (cUTI), even as the nation grapples with the growing problem of antibiotic resistance.

Nabriva's Contepo, chemically known as fosfomycin, is the first intravenously administered drug from a new class of antibiotics called epoxide in the United States, the company said.

In the following press release issued by the organisation, it pointed out that the Complete Response Letter (CRL) requests that Nabriva address issues related to facility inspections and manufacturing deficiencies at one of Nabriva's contract manufacturers prior to the FDA approving the NDA. Nabriva plans to request a "Type A" meeting to discuss the FDA's findings. The FDA did not request any new clinical data and did not raise any concerns with regard to the safety of CONTEPO.

"We will be working with the FDA in the coming weeks to gain a full understanding of the FDA's comments, with the goal of bringing this important treatment to patients as quickly as possible," said Ted Schroeder, Chief Executive Officer of Nabriva Therapeutics.

CONTEPO (fosfomycin) for injection, (previously referred to as ZTI-01 and ZOLYD) is a novel, potentially first-in-class in the United States, intravenous investigational antibiotic with a broad spectrum of Gram-negative and Gram-positive activity, including activity against most contemporary multi-drug resistant (MDR) strains such as ESBL-producing Enterobacteriaceae.

Intravenous (IV) fosfomycin has been approved for a number of indications and utilized for over 45 years outside the U.S. to treat a variety of infections, including cUTIs and other serious bacterial infections. CONTEPO utilizes a new dosing approach, originally developed by Zavante (which Nabriva Therapeutics acquired), to optimize its pharmacokinetics and pharmacodynamics. Nabriva Therapeutics believes these attributes, along with the positive clinical experience worldwide, support CONTEPO as an early appropriate treatment for cUTIs, including acute pyelonephritis, suspected to be caused by MDR pathogens. An estimated 40 percent of cUTIs are suspected to be caused by MDR bacteria and limited treatment options are available in the U.S. for these patients.

Read Also: Cipla gets USFDA nod for Ambrisentan tablets to treat pulmonary arterial hypertension

At least 2 million Americans develop serious infections from antibiotic-resistant bacteria, resulting in nearly 23,000 deaths annually, according to the Centers for Disease Control and Prevention.

Read Also: GSK gets USFDA nod for Benlysta to treat pediatric patients with lupus