NUNZIUM

Infection by the bacterium C. difficile (CDI) is a severe and potentially deadly disease that impacts people across the globe. CDI causes debilitating symptoms such as severe diarrhoea, fever, stomach tenderness or pain, loss of appetite, nausea and colon inflammation. The U.S. Centers for Disease Control and Prevention declared CDI a public health threat requiring urgent and immediate action. The infections cause an estimated half a million illnesses and tens of thousands of deaths annually in the U.S. alone. It is often the start of a vicious recurrence cycle, implying a significant burden for patients and the healthcare system. It has been estimated that up to 35% of CDI cases recur after initial diagnosis, and people who have had a recurrence are at significantly higher risk of further infections. After the first recurrence, it has been estimated that up to 65% of patients may develop a subsequent recurrence. On November 30, the Food and Drug Administration (FDA) approved "Rebyota", commercialized by Ferring pharmaceuticals. What makes this drug exceptional and a first of its kind is its manufacturing and delivery method. The drug is manufactured in Minnesota from stool donations screened for dozens of infections and viruses. Health professionals deliver the therapy via the rectum as a one-time procedure. The studies worth the FDA approval demonstrated that 70% of patients taking Rebyota saw their symptoms resolve after eight weeks, compared with 58% of patients getting a placebo. The new treatment is only for patients who have already taken a course of antibiotics for recurrent infections. The condition is more common in seniors and people with weakened immune systems.