An FDA advisory panel gave its unanimous recommendation for a new antibiotic to treat Clostridium difficile- associated diarrhea, commonly known as C. diff.
The drug is fidaxomicin, which will be sold under the name Dificid.
If the FDA gives its final approval, it will be the first new drug for treatment of C. diff infections in nearly 30 years. Right now, the only FDA approved treatment is Vancomycin. Metronidazole is another commonly used treatment, but it is used off label.
In making its decision, the advisory committee looked at two randomized clinical trials comparing the efficacy of fidaxomicin with vancomycin in their decision.
The studies showed that both drugs had roughly the same cure rate, However, they also showed that fidaxomicin worked significantly better at preventing future recurrences of the infection.
However, FDA panel members were split in its vote on whether it believes the drug works better than vancomycin at preventing recurrences.
The FDA is expected to make its final decision by May 30th, and the drug could be on the market by this summer. The cost of the drug has not yet been determined.
Fidaxomicin, developed by San Diego based Optimer Pharmaceuticals, is the first in a new class of antibiotics that was designed specifically to target C. diff bacteria.
It is an oral antibiotic that targets the intestines, with very little absorption throughout the rest of the body. So it has limited side effects.
In addition, the drug can quickly kill C. diff without disrupting the good intestinal bacteria, as other vancomycin and other broad-spectrum antibiotics do.
This bacteria keeps the intestines functioning normally, leading to a quicker return to health and a smaller chance of re-infection.
Most people who develop C. diff are in hospitals or long term care facilities, however, a small number of people have it naturally in their gut.
The infection usually occurs after the person has been started on broad spectrum antibiotics, which kill the good bacteria, allowing C. diff to take over. The bacteria release toxins which destroy the lining of the intestines, producing severe diarrhea and inflammation. With certain strains of the bacteria, infection can be overwhelming and deadly.
The Center for Disease Control and Prevention says C.diff cases are on the rise. One recent study says there were an estimated 700,000 cases last year.