Aemcolo FDA approval : Cosmo Technologies has bagged approval from the US Food and Drug Administration (FDA) for its antibacterial drug Aemcolo (rifamycin) for the treatment of a type of travelers’ diarrhea.
Aemcolo FDA approval
The FDA approval for Aemcolo is for the treatment of adult patients with travelers’ diarrhea because of noninvasive strains of Escherichia coli (E. coli), not complicated by fever or blood in the stool.
Commenting on Aemcolo FDA approval, Edward Cox – director of the Office of Antimicrobial Products in the FDA’s Center for Drug Evaluation and Research, said: “Travelers’ diarrhea affects millions of people each year and having treatment options for this condition can help reduce symptoms of the condition.”
Aemcolo’s efficacy was proven in a randomized, placebo-controlled clinical trial featuring 264 adults with travelers’ diarrhea in Guatemala and Mexico. The trial demonstrated that the antibacterial drug reduced symptoms of travelers’ diarrhea to a significant extent in comparison to placebo.
Administered orally over three or four days, Aemcolo’s safety was assessed across 619 adults with travelers’ diarrhea in two controlled clinical studies. Headache and constipation were the most common adverse reactions with the antibacterial drug in the trials.
According to the FDA, Aemcolo was not demonstrated to be effective in patients with diarrhea complicated by fever and/or bloody stool or diarrhea caused by pathogens other than noninvasive strains of E. coli and is not recommended for use in such patients.
Also, Aemcolo should not be used in patients who are hypersensitive to rifamycin, any of the other rifamycin class antimicrobial agents or any of the components in the antibacterial drug.
Prior to the Aemcolo FDA approval, the drug was granted a Qualified Infectious Disease Product (QIDP) designation from the regulator. The QIDP designation is granted under the Generating Antibiotic Incentives Now (GAIN) title of the FDA Safety and Innovation Act to antibacterial and antifungal drug products developed for the treatment of serious or life-threatening infections.
Under the QIDP designation, Aemcolo’s marketing application was given Priority Review under which led to an expedited approval by the FDA.