The number of cases for additional indications of ulcerative colitis after the domestic market launch of Janssen Korea’s Simponi, an autoimmune disease drug, has been adjusted to 120. Janssen Korea should accordingly conduct an additional investigation for a year and a half to check for adverse reactions such as severe infections.
The Ministry of Food and Drug Safety released online on Thursday the results of the discussions it had with the Central Pharmaceutical Affairs Advisory Committee on the adjustment of the number of the post-marketing cases filed by Janssen Korea.
Simponi is a drug for autoimmune diseases with indications for rheumatoid arthritis, psoriatic arthritis, psoriatic arthritis, condylar arthritis and ulcerative colitis. Medications that have added other manifest effects can be reassessed separately for the indications, according to the Article 22 of the Regulations for Drug Safety.
Janssen Korea had met the criteria for the post-marketing surveillance cases for other indications but not for that of ulcerative colitis. According to the standard, it had to survey 600 people but did so in only 80 by the deadline.
The company requested for an adjustment arguing that adverse reaction that indicates severe infections can be observed in about 80 patients. The sample size to observe severe infection, such as opportunistic infection or tuberculosis, for which one of the common abnormal cases listed in “Usage Precautions” is 45, the company said.
“Biologics is not used much for ulcerative colitis as it can be easily cured with existing chemical drugs. As a gastrointestinal specialist I understand that the number of cases could not be met for such reasons,” said a committee member, noting that Janssen Korea’s filing is valid.
Opinions were raised, however, that 80 patients are not enough to confirm severe adverse reactions.
Another committee member said, “Since the incidence rate of serious infection is 6.8 percent, 45 cases are required when statistically calculating the number of cases that can observe more than one example. The 80 cases presented are statistically sufficient, but more consideration is needed to decide if it is enough as the target.”
Accordingly, the committee members agreed that it is appropriate to survey 120 cases, and instructed the company to investigate 40 more patients for a year and a half based on the monthly usage records.
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