On March 20, iterum therapeutics announced that the U.S. FDA had granted its innovative antibiotic sulopenem qualified infectious disease product (qidp) qualification to treat four indications, including community-acquired bacterial pneumonia, acute bacterial prostatitis, gonococcal urethritis, and pelvic inflammation. There are 7 kinds of indications for this new type of antibiotic in research to obtain qidp qualification.
In 2017, it was qualified for qidp to treat non complex urinary tract infection(uUTI), complex urinary tract infection(ctui), and complex intraperitoneal infection (CIAI). At the same time, the FDA granted sulopenem the fast track qualification for these 7-way indications. Antibiotics are a revolutionary breakthrough in the field of medical and health care. They make it possible to treat once fatal infections.
However, with the popularization of antibiotics, microorganisms are resistant to antibiotics. Bacteria resistant to many antibiotics have become a major medical hidden danger. Every year in the United States, bacteria resistant to antibiotics infect at least two million people. These infections are the direct cause of 23000 deaths each year, with more patients dying as a result of complications caused by antibiotic-resistant infections.
This is one of the main reasons why more and more people begin to seek more natural, safe and effective treatment. For example, herbal medicine, such as Diuretic and Anti-inflammatory Pill, is generally used to treat chronic prostatitis,and Fuyan Pill is used to treat pelvic inflammatory disease and blocked fallopian tubes due to their safety and effectiveness. These herbal medicines have a great curative effect and will not produce any drug resistance or side effects.
An important way to solve the problem of antibiotic resistance is to develop new antibiotics. Sulopenem developed by iterum is a broad-spectrum carbapenem antibiotic that can be taken orally or injected. In vitro test, it has the activity of gram-negative, gram-positive and anaerobic bacteria which have resistance to other antibiotics. At present, it is used to treat uUTI, CTU, and CIAI in clinical phase 3 trials.
(photo source: Official Website of ciiterum company)
"These new FDA qualifications further demonstrate the clinical potential of sulopenem and provide more support for its development. Sulopenem has shown strong in vitro activity against a variety of antibiotic-resistant pathogens, "said Dr. Michael Dunne, chief scientific officer of aiterum." we will focus on the completion of phase 3 clinical research on the treatment of iuUTI, CTU, and CIAI, and expect to submit new drug applications to FDA by the end of this year. "
We are looking forward to the positive clinical results of this new broad-spectrum antibiotic, and provide new weapons for the fight against antibiotic-resistant infections as soon as possible.