Astellas Korea received administrative punishment for changing details of two clinical trials on a rheumatoid arthritis drug without regulatory approval.
The Ministry of Food and Drug Safety on Tuesday ordered the company to suspend the two trials on “ASP015K,” a rheumatoid arthritis treatment, for 45 days, and patient recruitment for 45 days.
ASP015K is a Janus kinase (JAK) inhibitor, drawing attention as oral medicine, like Pfizer’s Xeljanz.
The ministry found that the company changed plans for two different clinical trials arbitrarily without the food and drug safety minister’s nod, and imposed aggravated punishment.
Under the Pharmaceutical Affairs Act and the Rules on Pharmaceutical Products, modifying clinical trials without approval can lead to a suspension of the test for one month at the first violation. However, the regulator could aggravate punishment if the company violated rules in more than two trials.
Astellas Korea has already completed recruiting patients for one of the two suspended studies. For the other, the company was in the process of hiring.
A pharmaceutical company must obtain regulatory approval to conduct a clinical trial. Under the Pharmaceutical Affairs Act, the company must win the food and drug safety minister’s permission to modify a trial.
In detail, changing a trial requires regulatory nod in the following cases: modification of the purpose of the study, a change in the applicant for the trial, and a change that significantly affects the safety of the test subjects or the reliability of the results.
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