Ulcerative Colitis Resource Center

Ulcerative Colitis Resource Center

August 25, 2014
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Three UC drugs approved by FDA

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As a disease with both chronic and acute manifestations, ulcerative colitis often requires a balancing act of maintenance and rescue therapies. In recent years, drugs with new mechanisms of action have been developed, offering options to meet the diverse needs of patients with this potentially debilitating condition. Healio.com presents news on three drugs recently approved by the FDA for the treatment of ulcerative colitis.

The appropriate treatment depends on the activity and severity of a patient’s ulcerative colitis (UC) and also may hinge on a patient’s ability to respond to or tolerate other treatment options.

In recent years, drugs with new mechanisms of action have been developed, offering options to meet the diverse needs of patients with this potentially debilitating condition.

Healio.com presents three drugs recently approved by the FDA for the treatment of ulcerative colitis.

Entyvio (approved in May 2014)

The most recent drug to receive FDA approval for UC is vedolizumab (Entyvio, Takeda Pharmaceuticals), which also was approved for Crohn’s disease, on the strength of five clinical trials.

The integrin receptor agonist is administered as injections for treating adult patients with moderate to severe UC or Crohn’s disease. Previously, these patients did not respond adequately to standard treatment with immunomodulators, corticosteroids, or tumor necrosis factor-alpha antagonists. Before approving vedolizumab, the FDA had called its safety into question, citing the potential risk for progressive multifocal leukoencephalopathy (PML) associated with its use. The FDA continues to monitor PML risk.

Simponi (approved in May 2013)

Golimumab (Simponi, Janssen Ortho Biotech), a tumor necrosis factor (TNF) inhibitor, was granted FDA approval and indicated for patients with moderate to severe UC. These patients required continuous steroid therapy or had been refractory to previous treatments.

Simponi already had received FDA approval for treating other autoimmune conditions, including ankylosing spondylitis and rheumatoid and psoriatic arthritis.

Uceris (approved in January 2013)

The FDA approved budesonide (Uceris, Santarus/Cosmo Technologies) for use in UC patients with active, mild to moderate disease. The corticosteroid is administered as extended-release, 9-mg tablets taken once daily for up to 8 weeks.

According to a company press release, the medication has side effects such as “headache, nausea, bloating, acne, urinary tract infection, joint and stomach pain, constipation, tiredness and a decrease in blood cortisol levels.” When used long term, budesonide also is associated with hypercorticism and inadequate steroid hormone production.