close

Products

Date: 2018-11-01

Type of information: Submission of a Market Application in the US

Product name: Contepo™

Compound: fosfomycin for injection

Therapeutic area: Infectious diseases

Action mechanism:

  • antibiotic. 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 (I.V.) fosfomycin has been approved for a number of indications and utilized for over 45 years in Europe 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.
  • Contepo™ has been granted Qualified Infectious Disease Product (QIDP) and Fast Track designations by the FDA for the treatment of several serious infections, including cUTI, which enables Priority Review of the NDA, following acceptance.

Company: Nabriva Therapeutics (Ireland)

Disease: complicated urinary tract infections (cUTIs), including acute pyelonephritis

Latest news:

  • • On November 1, 2018, Nabriva Therapeutics announced it has submitted a New Drug Application (NDA) to the FDA to seek marketing approval for its investigational intravenous antibiotic, Contepo™ (fosfomycin for injection) to treat complicated urinary tract infections (cUTIs), including acute pyelonephritis.
  • The NDA submission is utilizing the 505(b)(2) regulatory pathway and is supported by a robust data package, including a pivotal Phase 2/3 clinical trial (known as ZEUS™), which met its primary endpoint of statistical non-inferiority to piperacillin/tazobactam in patients with cUTI, including acute pyelonephritis.

Patents:

Submission of marketing authorization application USA :

Submission of marketing authorization application UE:

Withdrawal of marketing authorization application USA:

Withdrawal of marketing authorization application UE:

US authorization:

UE authorization:

Favourable opinion UE:

Favourable opinion USA:

Orphan status USA:

Orphan status UE:

Pediatric exclusivit _USA:

Pediatric exclusivity UE:

OTC status:

Other news:

Is general: Yes