On June 20th, Motif Bio, an antibiotic new drug research and development company, announced that it has submitted a new drug marketing application (NDA) for the drug iclaprim to the US FDA. On August 14, the company announced that the US FDA has accepted NDA from iclaprim, a targeted drug for Gram-positive bacteria intended to treat acute bacterial skin and skin structure infections (ABSSSI). This decision means that the FDA has determined the completeness of the application and is sufficient for a substantive review. For the NDA application, the FDAFA date determined by the US FDA is February 13, 2019.
Motif Bio CEO Graham Lumsden said: "The FDA's recognition of NDA is an important milestone for us. I believe that if the drug is approved, iclaprim may become an important new treatment for patients with severe skin infections. We look forward to working closely with the FDA. And strive to pass the review process in order to bring better therapeutic options to patients as soon as possible."
In the United States, there are more than 3.6 million patients hospitalized for ABSSSI each year. It is estimated that up to 26% of hospitalized ABSSSI patients have kidney damage. Hospitalized patients with obesity, diabetes, and/or renal dysfunction are particularly susceptible to kidney damage caused by standard therapy vancomycin-related drugs. Many standard Gram-positive antibiotics are not suitable for treating such hospitalized ABSSSI patients due to efficacy and/or safety issues.
The NDA included two clinical trials of REVIVE-1 and REVIVE-2 for assessing the efficacy of ABSSSI patients. In both trials, iclaprim reached the primary end point of study compared to the current standard of care, vancomycin, which was the case for patients with intention-to-treat (ITT) who started taking iclaprim for 48-72 hours at an early time point. Effect (NI) (10% margin) results. In the end point of the test, the drug reached the NI (10% margin) 7-14 days after the ISTlaprim was discontinued in ITT patients.
Iclaprim is certified by the US FDA for Qualified Infectious Disease Products (QIDP). If the drug is approved for marketing as a new chemical entity in the form of QIDP, it will be eligible for 10 years of market exclusive treatment in the United States from the date of approval, under the US Generating Antibiotic Incentives Now Act.
Iclaprim molecular structure (from Wikipedia)
Iclaprim is a novel antibiotic that has antibiotics that target Gram-positive bacteria. Unlike commonly used broad-spectrum antibiotics, this “precise medical approach” complies with antibiotic management principles and can reduce inappropriate use of broad-spectrum products to avoid accumulation of resistance and reduce the impact on the patient's microbiota. So far, the drug has been studied in more than 1,400 patients and healthy volunteers. Clinical and microbiological data indicate that Iclaprim has a targeted Gram-positive activity profile, low drug resistance propensity and good tolerance.
