Crohn’s disease is a painful condition that causes inflammation or swelling of the bowels and impacts the gastrointestinal tract. It affects as many as 700,000 Americans at any given point. In fact, more than half of a million people in the U.S. have been diagnosed with this condition. Some common symptoms include abdominal cramps, fever, constipation, fatigue, and weight loss.

Ulcerative colitis is also a serious disorder in which a person feels severe abdominal pain, fatigue, and low energy. This inflammatory disease also causes ulcers in the inner lining of the large intestine. Ulcerative colitis can also lead to gastrointestinal bleeding and diarrhea. It affects approximately 620,000 people across the United States.

In recent months, a new treatment was approved by the U.S. Food and Drug Administration (FDA) to heal these two medical conditions. According to a press release from the organization in May 2014, the FDA approved the Entyvio (vedolizumab) injection to help adult patients who have either Crohn’s disease or ulcerative colitis.

This new medication is advised for use in patients who were not adequately treated with standard therapies like corticosteroids, immunomodulators, or tumor necrosis factor blocker drugs.

“Ulcerative colitis and Crohn‘s disease are debilitating diseases that impact the quality of life of those who have these conditions,” Dr. Amy G. Egan, acting deputy director of the Office of Drug Evaluation III in the FDA‘s Center for Drug Evaluation and Research, said in the press release. “Although there is no cure for these conditions, today‘s approval provides an important new treatment option for patients who have had an inadequate response to conventional therapy to help control their symptoms.”

Two clinical trials following 900 patients were used to establish the safety and effectiveness of the Entyvio injection for treating ulcerative colitis. All of these patients did not adequately react to standard therapies for their condition. The subjects were evaluated through endoscopic tests, rectal bleeding, gastrointestinal health, and a physician’s summary.

The results from the clinical trials illustrate that the subjects treated with Entyvio fared better than those on a placebo and also had superior appearance of the colon during endoscopy. Most importantly, the patients that took Entyvio achieved and maintained clinical remission.

When the Entyvio injection was used to determine the treatment for Crohn’s disease, more than 1,500 patients were followed in three separate clinical trials. Once again, these subjects did not respond well to standard therapies like immunomodulators or tumor necrosis factor blocker medications. These trials showed similar results in which patients who took Entyvio displayed greater clinical response and corticosteroid-free clinical remission.

The medication Entyvio is an integrin receptor antagonist, which blocks certain proteins found on the surface of cells such as those residing on circulating inflammatory cells. Essentially, this stops the movement of inflammatory cells into certain areas of the gastrointestinal tract.

Before any drug goes through human clinical trials, it must first be examined in pharmacological studies and pre-clinical animal models. Including animal model studies was vital for the development of the Entyvio injection and many other medications.

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Categories: Inflammatory diseases

Tags: crohn's disease, entyvio, FDA, ulcerative colitis