There is new hope for the hundreds of thousands of Americans that suffer from ulcerative colitis and Crohn’s disease. The FDA has recently approved a new drug to treat adults with moderate to severe cases of both conditions. This new drug, Entyvio, will hopefully help patients who are unable to find relief from previous treatment.
Created by the Japanese pharmaceutical company Takeda, Entyvio (vedolizumab), showed amazing results in its clinical trials, Pharmaceutical Business Review reported. Entyvio successfully secured remission in adult patients suffering from UC who either had bad reactions, poor responses, or showed a dependency to other UC medications. “The clinical trial program evaluated the efficacy and safety profile of Entyvio and demonstrated that Entyvio has the potential to help adult patients with moderately to severely active UC or CD successfully manage their disease," Stephen Hanauer, medical director at Northwestern University Feinberg School of Medicine, explained to PBR.
“Ulcerative colitis and Crohn‘s disease are debilitating diseases that impact the quality of life of those who have these conditions,” said Dr. Amy G. Egan, acting deputy director of the Office of Drug Evaluation III in the FDA's Center for Drug Evaluation and Research, in an FDA 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,” Egan continued.
The drug’s approval was based on combined results from four clinical trials. These were the largest Phase III clinical trials to ever have been simultaneously conducted on both UC and Crohn’s disease patient populations. More than 2,700 patients were involved from nearly 40 countries, PBR reported. Results showed that a greater percentage of participants treated with Entyvio maintained remission in comparison to those who took the placebo.
How does it work?
Entyvio works by blocking chronic inflammation, one of the main causes of discomfort in UC and Crohn’s disease patients. Entyvio is an integrin receptor antagonist and blocks the integration of specific integrin receptors with a specific protein. The result of this is limited migration of circulating inflammatory cells across blood vessels and into areas of inflammation in the gastrointestinal tract. Entyvio’s most common side effects are headache, joint pain, nausea, and fever. The more serious side effects are infection, hypersensitivity, and infusion-related reaction, and hepatotoxicity.
New Options for UC and CD Patients
Entyvio is not a miracle medicine for UC and Crohn’s disease but merely another choice for patients who had otherwise run out of options. Many drugs currently used to treat the conditions have unpleasant and even dangerous side effects. For example, corticosteroids, which help to reduce inflammation, can cause insomnia, hyperactivity, high blood pressure, and even diabetes. Other medications, such as TNF (tumor necrosis factor) blockers, carry the risk of infections such as tuberculosis. Also, these medications do not work for every patient, which emphasizes the need for more variety in gastrointestinal drugs. Entyvio has been approved for a 300 milligram dose to be infused intravenously over 30 minutes at zero, two, and six weeks; then every eight weeks.
Although approved for us in the U.S., Takeda is still waiting for a response from the European Commission on approval for marketing authorization of Entyvio.