FDA Approves Zeposia for Ulcerative Colitis

Individuals with ulcerative colitis will have a new treatment after the approval of Zeposia by the FDA. The drug is effective for moderate and severe ulcerative colitis, a type of inflammatory bowel disease. It results when inflammation occurs in the lining of the rectum, large intestine, or both.

Studies indicate that about three million US adults have ulcerative colitis. The inflammation begins at the small intestine and travels upwards. In severe ulcerative colitis, the inflammation may involve the whole colon.

Although there are numerous therapies for ulcerative colitis, most patients do not respond to them. Approval of the drug with a novel mechanism like ozanimod is a significant breakthrough for the patients. However, it remains to be seen where the drug will lie in the treatment algorithm.

Zeposia is the latest to be approved by the FDA among drugs used for the symptomatic management of ulcerative colitis. The severity of ulcerative colitis symptoms may vary from one person to the other. However, common symptoms associated with ulcerative colitis are abdominal pain, bloody stool, diarrhea, weight loss, rectal pain, malnutrition, and abdominal sounds. In addition, ulcerative colitis may cause skin problems, joint swelling, and joint pain.

Currently, removing the colon through surgical procedures is the only potential definitive management for ulcerative colitis. However, there are other medications effective in symptomatic management. For example, Zeposia also seems to be effective against the relapsing forms. However, phase three clinical trials are still underway to assess the efficacy and safety of the medication.

Mechanism of Action of Zeposia

The exact mechanism of action of the drug is unknown. However, it is believed to reduce the migration of T lymphocytes into the intestine. Additionally, Zeposia prevents the migration of immune cells from the lymph nodes into the central nervous system. Because the drug acts as a gatekeeper, the CNS is protected from damage by the immune cells.

Results of the Clinical Trials

Approval of the drug was based on the data obtained from the True North study. A multicenter, double-blind, randomized, and placebo-controlled clinical trial study involved over 600 participants.

The patients did not receive a significant response from traditional therapies like immune modulators, corticosteroids, amino-salicylates, or biological drugs. Participants were on corticosteroids or oral amino-salicylates before and during the induction phase.

By week 10, 18% of the participants who were on Zeposia reached clinical remission. The latter compares to the 6% in the group of placebos. The response was 60% against 41%. Clinical remission in corticosteroid-free was 32% in the group of Zeposia against 17% in the placebo. These results show that Zeposia undoubtedly offers an additional clinical advantage.

The drug demonstrated efficacy in safety, histological mucosal improvement, endoscopic and clinical remission in True North. All the above parameters are vital in people with ulcerative colitis.

What You Need to Know About Zeposia

Zeposia is an oral pill taken once daily. It is available in the dose of 0.23, 0.46, and 0.92 milligrams. The active pharmaceutical ingredient is ozanimod which is an immune modulator. The drug is a game-changer for patients with ulcerative colitis who are unresponsive to the traditional regimen. Currently, the drug is available as a brand medication and not generic.

Side Effect

The drug can have mild or severe side effects. Therefore, it is advisable to consult your doctor to advise on the effective way of managing side effects. Mild side effects include:

  • Decreased white blood cells which may predispose you to other infections
  • Pain in the belly, especially in the initial phase of treatment with Zeposia. However, pain does not warrant discontinuation of treatment
  • Urinary tract infection
  • Respiratory tract infection
  • Orthostatic hypotension, which may precipitate episodes of fainting

The above side effects may resolve within a few days or a couple of weeks. However, if the symptoms persist, promptly inform your physician or pharmacist. For persons on Zeposia, your physician should advise you on lifestyle modifications to mitigate the side effects associated with the drug.

During the clinical studies, 26% of people with ulcerative colitis who took Zeposia developed upper respiratory tract infections like bronchitis. The condition also occurred in 23% of participants who were on interferon beta-1a.

The symptoms associated with upper respiratory tract infections (URIs) are sore throat, stuffy nose, cough, and fever. Therefore, patients on Zeposia who experience URI symptoms should inform their physicians to help them feel comfortable by recommending various medications.

The drug can lower forced expiratory volume leading to breathing challenges. Although the condition can also be associated with other allergic diseases, it’s appropriate to inform your doctor if you notice a decline in lung function.

Studies reveal that significant adverse effects of the drug may be in patients who recently suffered a myocardial infarction. Additionally, the side effects of Zeposia are seen more in persons with other cardiac conditions like heart failure and unstable angina. Therefore, the drug is also contraindicated in:

  • Patients taking monoamine oxidase inhibitors
  • Patients with chronic untreated sleep apnea
  • People with sinoatrial block and without any functioning pacemaker
  • Second or third-degree AV block

The drug was observed to delay atrioventricular conduction and lower heart rate. Bradycardia observed in the clinical trial may be associated with dose titration in the first week of therapy.

Hence, the need to carry out pre-treatment ECGs in all patients, including those with a history of heart block, heart failure, and recent myocardial infarction. Symptoms associated with reduced heart rate are shortness of breath, confusion, lightheadedness, weakness, and fatigue.

The asymptomatic rise in the liver enzymes and rates of herpes zoster were observed with the ozanimod. Although it is a non-selective sphingosine 1-phosphate, clinical trials involve more selective S1P modulators. The aim is to assess if increased selectivity will improve efficacy and safety. More on effectiveness and safety will be available in the post-approval studies.

Approval of Zeposia is a significant breakthrough towards getting more targeted therapies for conditions like ulcerative colitis.