FDA approvals

FDA approves Entyvio for ulcerative colitis, Crohn’s disease

The FDA has approved vedolizumab injections for the treatment of adult patients with moderate to severe ulcerative colitis and Crohn’s disease who failed to achieve adequate results from standard therapies, according to a press release.

The approval of vedolizumab (Entyvio, Takeda Pharmaceuticals) follows results from five clinical trials, two of which involved approximately 900 patients with ulcerative colitis (UC) for whom immunomodulators, corticosteroids or tumor necrosis factor-alpha antagonists were inadequate. In these trials, a greater percentage of participants who received Entyvio — an integrin receptor antagonist that blocks the migration of circulating inflammatory cells into inflamed areas in the GI tract — compared with placebo achieved and maintained clinical response and remission. They also achieved corticosteroid-free clinical remission and had improved colonic appearance observed during endoscopy.

In the three trials for an estimated 1,500 participants with Crohn’s disease, a greater percentage of patients who received Entyvio treatment vs. placebo achieved clinical response, clinical remission and corticosteroid-free clinical remission.

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

The most common side effects reported were headache, joint pain, nausea, and fever. The most serious risks included serious infections, hypersensitivity and infusion-related reactions, and hepatotoxicity.

In addition, another integrin receptor antagonist has been associated with progressive multifocal leukoencephalopathy (PML), a rare and often fatal viral infection of the central nervous system typically seen in patients with compromised immune systems. Entyvio participants were actively monitored for PML, and although no cases were identified, risk remains, the release said. Accordingly, the FDA advises health care providers to monitor patients on Entyvio for new onset or worsening of neurological symptoms, while it continues to investigate PML risk.

The FDA has approved vedolizumab injections for the treatment of adult patients with moderate to severe ulcerative colitis and Crohn’s disease who failed to achieve adequate results from standard therapies, according to a press release.

The approval of vedolizumab (Entyvio, Takeda Pharmaceuticals) follows results from five clinical trials, two of which involved approximately 900 patients with ulcerative colitis (UC) for whom immunomodulators, corticosteroids or tumor necrosis factor-alpha antagonists were inadequate. In these trials, a greater percentage of participants who received Entyvio — an integrin receptor antagonist that blocks the migration of circulating inflammatory cells into inflamed areas in the GI tract — compared with placebo achieved and maintained clinical response and remission. They also achieved corticosteroid-free clinical remission and had improved colonic appearance observed during endoscopy.

In the three trials for an estimated 1,500 participants with Crohn’s disease, a greater percentage of patients who received Entyvio treatment vs. placebo achieved clinical response, clinical remission and corticosteroid-free clinical remission.

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

The most common side effects reported were headache, joint pain, nausea, and fever. The most serious risks included serious infections, hypersensitivity and infusion-related reactions, and hepatotoxicity.

In addition, another integrin receptor antagonist has been associated with progressive multifocal leukoencephalopathy (PML), a rare and often fatal viral infection of the central nervous system typically seen in patients with compromised immune systems. Entyvio participants were actively monitored for PML, and although no cases were identified, risk remains, the release said. Accordingly, the FDA advises health care providers to monitor patients on Entyvio for new onset or worsening of neurological symptoms, while it continues to investigate PML risk.