Also, because infliximab was only studied in the sickest Crohn's patients, the panel said, not enough information is known on whether to use it in patients with milder cases and to prevent disease progression. Crohn's disease is named for Dr. Burrill Crohn, who is credited with first describing it, at Mount Sinai Medical Center in New York several decades ago. Most people with the disease undergo an operation to remove affected sections of the bowel. Such surgery often has to be repeated, because the disease tends to recur in areas adjacent to those removed. Among its famous victims was President Dwight Eisenhower.
Infliximab is a monoclonal antibody.
Monoclonals are proteins that are designed to home in on a specific biological target. It is because TNF is also thought to play a role in rheumatoid arthritis that infliximab is being studied as a treatment for that disease as well. The advisory panel's recommendation is expected to give a significant boost to the development of monoclonal antibodies, a research approach nearly abandoned because of a lack of success a decade ago. At the time of the NDA submission, the FDA promised a review within six months. Many such drugs, including antibiotics and steroids, can be dangerous if taken for long periods of time, and their benefits often wear out.