The FDA approved the drug Simponi for a type of chronic bowel disease called ulcerative colitis, which was resistant to other treatments.
Ulcerative colitis (UC) is a chronic disease that affects about 620,000 Americans. It causes inflammation and sores called ulcers in the inner lining of the large intestine which includes the colon and the rectum –– the end part of the colon. It is one of two main forms of chronic inflammatory bowel disease. The inflammation can lead to abdominal discomfort, gastrointestinal bleeding, production of pus and diarrhea.
UC is one of the two main forms of chronic inflammatory disease of the gastrointestinal tract, called inflammatory bowel disease (IBD). The other type is called Crohn's disease. Generally, the large intestine absorbs water from stool and solidifies it. In UC, the inflammation causes loss of the lining of the colon, leading to bleeding, production of pus, diarrhea, and abdominal discomfort.
Simponi works by blocking a molecule which plays an important role in causing abnormal inflammation and immune responses.The drug was previously approved to treat rheumatoid arthritis, psoriatic arthritis and arthritis affecting the joints in the spine and the pelvis, Simponi is now approved to treat adults with moderate to severe ulcerative colitis that is resistant to previous treatment or requires continuous steroid therapy.
"Simponi is an important new treatment option for patients with moderate to severe ulcerative colitis," Andrew E. Mulberg, M.D., deputy director of the Division of Gastroenterology and Inborn Errors Products in the FDA's Center for Drug Evaluation and Research, said in a press release. "It is critical that patients suffering from the serious and painful symptoms of ulcerative colitis have additional treatment options since patients experience the effects of the disease and respond to treatments differently."
The safety and effectiveness of Simponi have been proven in scientific studies. The experts looked into stool frequency, rectal bleeding, pictures of inside the bowel, and the general impression of the physician.
In the first study, experts assigned the drug to 513 patients with moderate to severe ulcerative colitis who could not tolerate or failed to respond to other therapies. Results showed that a larger number of Simponi-treated patients showed good response in terms of improvement in symptoms, and overall relief. As the doctors looked inside the patients' bowel after the treatment, they noticed improved appearance of the colon after six weeks compared with the patients who were not administered the drug.
In the second study, the experts took the 310 patients with moderate to severe ulcerative colitis who responded to Simponi and randomly assigned the drug. The findings suggest that a greater proportion of Simponi-treated patients continue to manifest good clinical response through week 54 and had clinical remission at both weeks 30 and 54.
Nonetheless, patients treated with Simponi need to watch out for upper respiratory infection and redness at the site of injection. They are also at increased risk of developing serious infections, invasive fungal infections, reactivation of Hepatitis B infection, lymphoma, heart failure, nervous system disorders and allergic reactions, according to the FDA press release.
