|From: burp (Rep: 73)||Date: 09/07/2018 08:40|
|Forum: Nabriva Therapeutics AG - Msg #79||Thread #674032884 (Rec: 0) |
|2 NDA's Both with over 90% likelyhood of FDA approval....128M MC is a joke...read------|
Nabriva expects to file New Drug Applications (NDAs) with the U.S. Food and Drug Administration for both lefamulin and CONTEPO in the fourth quarter of 2018.”
CONTEPO™ (fosfomycin for injection, previously referred to as ZTI-01 and ZOLYD), is Zavante Therapeutics’ novel, potentially first-in-class in the United States, intravenous investigational antibiotic. CONTEPO is in development to treat serious infections, including those caused by multi-drug resistant Gram-negative and Gram-positive bacteria. Outside of the United States, IV fosfomycin has been used broadly for over 45 years to treat a variety of indications, including complicated urinary tract infections (cUTIs) and other serious bacterial infections. In recent years, IV fosfomycin has seen increasing use for treatment of serious infections caused by MDR Gram-negative bacteria. Zavante has been developing CONTEPO with the objective of establishing CONTEPO as a standard of care in the United States for hospitalized patients with serious infections caused by suspected or confirmed MDR bacteria. Zavante has completed a pivotal Phase 2/3 clinical trial (ZEUS™) with respect to CONTEPO for the treatment of cUTIs and has initiated a pediatric clinical trial. In April 2017, Zavante announced that CONTEPO met the primary endpoint of statistical non-inferiority to piperacillin/tazobactam in the ZEUS™ clinical trial in patients with cUTI, including acute pyelonephritis (AP). CONTEPO has been granted Qualified Infectious Disease Product (QIDP) and Fast Track designations by the U.S. Food and Drug Administration (FDA) in several indications, including cUTI. Nabriva Therapeutics expects to file a New Drug Application (NDA) utilizing the FDA’s 505(b)(2) pathway in the fourth quarter of 2018.
Lefamulin is a semi-synthetic pleuromutilin discovered and developed by the Nabriva Therapeutics team. It is designed to inhibit the synthesis of bacterial protein, which is required for bacteria to grow. Lefamulin’s binding occurs with high affinity, high specificity and at molecular sites that are different than other antibiotic classes. Nabriva Therapeutics has completed two pivotal Phase 3 trials evaluating the safety and efficacy of lefamulin for the treatment of adults with community-acquired bacterial pneumonia (CABP). In both studies, lefamulin met all primary and secondary endpoints and was shown to be generally well tolerated. As a result of the favorable safety and tolerability profile observed in clinical trials to date, Nabriva Therapeutics believes lefamulin represents a potentially important new treatment option for the approximately three million adults in the United States diagnosed with CABP in the hospital setting each year.
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