Nabriva Therapeutics Announces Acceptance of the New Drug Application for Intravenous Contepo to Treat Complicated Urinary Tract Infections by FDA
DUBLIN, Ireland, Jan. 04, 2019 (GLOBE NEWSWIRE) -- Nabriva Therapeutics plc (NASDAQ: NBRV), a clinical-stage biopharmaceutical company engaged in the research and development of innovative anti-infective agents to treat serious infections, announced that the U.S. Food and Drug Administration (FDA) has accepted the New Drug Application (NDA) and granted a priority review for Contepo™ (fosfomycin for injection) to treat complicated urinary tract infections (cUTIs), including acute pyelonephritis. The acceptance of the NDA indicates that the FDA has deemed the application sufficiently complete to allow a substantive review. The PDUFA (Prescription Drug User Fee Act) goal date for the completion of the FDA’s review of the Contepo NDA is June 30, 2019. In addition to priority review, 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.
“The acceptance of the Contepo NDA marks another major milestone for Nabriva Therapeutics, demonstrating our commitment to bring novel anti-infective agents that address the urgent, unmet medical need in patients with serious infections,” said Dr. Jennifer Schranz, chief medical officer of Nabriva Therapeutics. “Contepo, if approved in the United States, represents a first-in-class intravenous antibiotic with broad spectrum activity against Gram-negative and Gram-positive organisms, including ESBL-producing Enterobacteriaceae and other contemporary multi-drug resistant (MDR) organisms.”
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.
In the NDA acceptance letter, the FDA stated that no filing or potential review issues were identified. In addition, the Agency stated that it has not referred Contepo to an advisory committee meeting at this time.
About cUTIs
Urinary tract infections (UTIs) are a significant health problem in both the community- and hospital-based treatment settings. It is estimated that 150 million UTIs occur yearly worldwide, accounting for $6 billion in health care expenditures, according to the American Urological Association. Patients who fail to respond to an initial course of antibiotics can go on to develop a cUTI, which occurs when the bacteria are embedded in the bladder wall where they can multiply more slowly and are much harder to address with antibiotics. In most cases, cUTIs occur following treatment for a normal UTI because antibiotics were given too late, for too short a period of time, at too low of a dose course or the wrong antibiotic was used and did not provide adequate spectrum of coverage. An estimated three million cases of cUTIs are treated in the hospital setting in the United States each year for Gram-negative infections. Enterobacteriaceae are the most common pathogens causing cUTIs and, currently, widespread antibiotic resistance limits the effective treatment options for cUTI. Ineffectively managed cUTI can lead to increased treatment failure rates, recurrence of infection, increased re-hospitalization, and increased morbidity and mortality.
About Contepo™
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. Nabriva Therapeutics believes these attributes, along with the positive clinical experience worldwide, support Contepo as a first-line treatment for cUTIs, including acute pyelonephritis, suspected to be caused by MDR pathogens. At least 20 percent of cUTIs are caused by MDR bacteria and limited treatment options are available in the U.S. In addition, non-clinical data have shown that Contepo acts in combination with certain other antibiotics to improve bacterial killing.
About Nabriva Therapeutics plc
Nabriva Therapeutics is a clinical-stage biopharmaceutical company engaged in the research and development of innovative anti-infective agents to treat serious infections. Nabriva Therapeutics has two product candidates that are in late stage development: lefamulin, potentially the first systemic pleuromutilin antibiotic for CABP and Contepo (fosfomycin for injection), a potential first-in-class epoxide antibiotic in the United States for complicated urinary tract infections (cUTIs) including acute pyelonephritis (AP). For
Many flies and flying insects in hospitals carry bacteria that could pose an infection risk to patients, and more than half of them carry the types that resist antibiotics, a new study says.
ReplyDeleteBritish researchers used ultraviolet-light flytraps, electronic fly killers and sticky traps to collect nearly 20,000 flies, aphids, ants, wasps, bees and moths at seven hospitals in England over 18 months, and found that almost 9 in 10 insects had potentially harmful bacteria on or in their bodies.
A total of 86 bacterial strains were found in the insects. Enterobacteriaceae -- a family that includes E. coli and Salmonella -- were the most common (41%), followed by Bacillus (which includes the food poisoning germ B. cereus) at 24% and staphylococci (which includes S. aureus, a cause of skin infections, abscesses and respiratory infections) at 19%.
In some cases, the level of bacteria carried by insects was enough to potentially cause infection in humans.
The findings show that "a variety of flying insects collected from U.K. hospitals do indeed harbor pathogenic bacteria of different species," said study lead author Federica Boiocchi, a Ph.D. student at Aston University in Birmingham.
The study also found that 53% of the bacterial strains on the insects were resistant to at least one class of antibiotics -- so-called "superbugs." Of those, 19% were resistant to multiple antibiotics.
Resistance was most common for penicillin, but resistance to other widely used antibiotics, including vancomycin and levofloxacin, was also found, according to the study.
"What's quite interesting, though, is the high proportion of drug-resistant bacteria found in these samples. It's a vivid reminder of how our overuse of antibiotics in health care settings is making infections more difficult to treat," Boiocchi said in a university news release.
The insects were collected from a number of areas of the hospitals, including those where food for patients, visitors and staff was prepared or stored, as well as wards, neonatal units and maternity units.
The highest numbers of insects were collected in the spring and summer.
Anthony Hilton, a professor of applied microbiology at the university, noted, "What we are saying in this paper is that even in the cleanest of environments, it's important to take steps to prevent bacteria being brought into hospitals by insects."
For women, predicting when they'll reach menopause is anyone's guess. But if you want to get some foresight, you should ask your mother.
ReplyDeleteFor most women, menopause begins at around 52. But for thousands of women it starts much later, and for some, a lot earlier. Those whose menopause starts later may also be looking at a longer life expectancy, researchers have found.
Smoking, chemotherapy and weight can affect the age when a woman's monthly periods stop.
But family history appears to be the most important factor, according to researchers led by Harold Bae, of Oregon State University's College of Public Health and Human Sciences. If your mother started menopause early, odds are you will, too, the investigators found.
In addition, "Genetic variants associated with later menopause have been found to be associated with longer life," said Dr. JoAnn Pinkerton. She is executive director of the North American Menopause Society.
"Although early menarche and total number of reproductive years have not been associated with slower aging, later menopause (longer reproductive potential) appears to be associated with slower aging," she said in a society news release.
For the study, Bae's team looked at several previously published studies. An analysis of the studies found that women who could have children after age 40 were four times more likely to live to 100 years or older. Women who had children at 35 or beyond were nearly two times more likely to live past 100.
The report was published online recently in the journal Menopause.