New oral ulcerative colitis drug Zeposia approved

to offer an expanded treatment options

Small number of Korean subjects in the trial...but offers a new drug option for patients

Authorities accepted the validity of the drug’s introduction to Korea after the company’s data submission

BMS Korea’s new ulcerative colitis treatment ‘Zeposia Cap (ozanimod)’ seems to have been granted marketing authorization for its effectiveness in broadening the treatment option for patients with ulcerative colitis despite the small number of clinical trial subjects.

 

The recent minutes of the Central Pharmaceutical Affairs Council that were recently disclosed by the Ministry of Food and Drug Safety revealed that the council had a discussion on the feasibility of applying the clinical trial results of an ulcerative colitis drug in Korea.

 

The minutes also mentioned that the ulcerative colitis treatment discussed by the CPAC had the ‘advantage of being taken once a day orally,’ indicating that an advisory meeting had been held for Zeposia ahead of its approval in February.

 

Zeposia is a sphingosine 1-phosphate receptor modulator used to suppress inflammation by preventing self-reactive lymphocytes from moving to the stomach in ulcerative colitis where immunomodulatory abnormalities are observed Zepocia is taken once a day and is indicated to treat moderate-to-severe active ulcerative colitis in ▲ patients who respond adequately to existing treatment or biological agents including corticosteroids, immunosuppressants, etc., or ▲ have no response, or ▲have resistance.

 

However, whether to grant Zepocia’s approval was discussed due to the small number of Korean subjects available in the clinical trial results submitted by the company for approval.

 

One committee member said, "Epidemiologically and statistically speaking, due to the small of Korean trial participants in the bridging data, the results of one or two patients can make a large difference in the results, rendering the judgment difficult.” The MFDS explained, “Population pharmacokinetics analysis data show that the drug’s pharmacokinetics in the total patient population and Koreans were similar.” Also, the MFDS explained that the US label shows that the AUC and Cmax increased in Japanese patients compared to Caucasians, but the difference was not clinically significant.

 

Also, discussions were made on what is the best indicator that can be used to evaluate the effectiveness of the ulcerative colitis treatment as the number of Korean subjects in the trial was insufficient to conduct a sub-analysis.

 

The members discussed whether clinical remission was the right indicator of clinical response efficacy, and whether to use any as secondary indicators in determining the efficacy of the discussed drug.

 

In this regard, a member said, “In ulcerative colitis, drugs are administered for a short period of time to induce remission, and steroids and mesalazine are used as maintenance therapy after the patient reaches a response.

 

When the condition progresses to a severe state, biological agents or immunomodulators are additionally used, then surgery if drug treatment is insufficient.” Since ulcerative colitis can be managed but not cured, there was also the opinion that inducing an initial remission only indicates that patients respond to the drug.

 

Also, another member claimed that although the clinical remission results may not be enough to determine the efficacy of the drug due to the small number of subjects, the clinical response results are in favor of its use in Korea.

 

A member said, “There are so many types of ulcerative colitis drugs with various mechanisms of action in the market because the treatment rate of the currently available treatments for the disease is low, and even this low response is often lost over time.

 

Therefore, if an effect can be seen with a drug that has a different mechanism of action, its addition will increase the number of treatment options for the patients to choose from.” Another member also agreed that the drug can be useful in terms of providing additional drug selection opportunities.