The U.S. Food and Drug Administration (FDA) granted fast-track designation for its experimental lupus treatment, Lupuzor. This status means that the review will be given priority to go faster than usual. FDA often grants this accelerated process to drugs that show promise in treating serious, life-threatening medical conditions for which no other drug either exists or works as well.
The FDA also gave its approval to the company that developed the drug, ImmuPharma to begin a Phase III clinical trial. A Phase III trial is often the last step before the company testing the drug submits an application to the FDA for it to be approved as a new treatment.
Lupuzor™ (previously known as IPP-201101) has a novel mechanism of action aimed at adjusting the body’s immune system so it does not attack healthy cells without causing adverse side effects. It has the potential to stop the progression of the disease in a substantial proportion of patients.
Check back to lupustrials.org for details when the Phase III trial is about to begin.