Olumiant re-examination period extended by 35 months

Additional indication stability information collection dimension

In March of this year, the post-sales investigation (PMS) plan of Lilly Korea Olumiant, which was approved for severe circular alopecia indications in adult patients over the age of 18 from the Ministry of Food and Drug Safety in March of this year, will also be changed.

 

According to the minutes of the meeting of the Central Pharmaceutical Review Committee held on August 16th and 18th, which was recently released by the Ministry of Food and Drug Safety, it was concluded that it is reasonable to extend the investigation period and change the subject in consideration of the current status of the usability permission to change the indication of the target after the market.

 

The original PMS period was six years, but this adds 35 months.

 

The subjects also decided to include 800 atopic dermatitis and 753 protomy alopecia with no change in the total number of cases in the existing 3000 cases (350 atopic dermatitis).

 

The rest of the cases are filled with patients with rheumatoid arthritis.

 

Olumiant is an oral autoimmune disease treatment with JAK inhibitory method, and it has only indications for rheumatoid arthritis at the time of approval in 2017, but it has additional efficacy and effect for atopic dermatitis in May 2021 and circular alopecia in March of this year.

 

Regarding the change in the number of PMS cases, Commissioner Han said, "The drug permit indications have been added sequentially, and the case composition and investigation period adjustment are reasonable for sufficient collection of safety information on the newly added indications." By April of this year, the actual cumulative number of PMS registered patients for rheumatoid arthritis and atopic dermatitis was 1214 cases of rheumatoid arthritis and 310 cases of atopic dermatitis, according to Commissioner Lee.

 

Another commissioner needed to adjust the number of cases at an appropriate level, but this time Olumiant agreed to adjust the number of cases filed by the company because the PMS period is very short.

 

Commissioner Lee emphasized, "After being applied to clinical practice, many rheumatoid patients improve, and it has a good effect on other rheumatic diseases such as psoriatic arthritis, so it is thought that there will be more applications in the future.

 

Patients with rheumatoid disease can be seen as a higher risk group related to cardiovascular side effects than patients with atopic circular alopecia, so it should be properly distributed to the patient group suitable for checking the side effects of drugs during the purpose of PMS." Regarding the existing recruitment of 3,000 cases, it was also said that it would be difficult to secure patients with rheumatoid arthritis as atopic dermatitis and prototype alopecia were added to the indications.

 

"Despite the addition of atopic dermatitis and circular alopecia to the efficacy items, this drug may not be able to secure enough patients with rheumatoid arthritis expected by the highest number of approved efficacy items, which may not fill the planned patients until December, which is the re-examination period," said one commissioner.

 

Excessive competition with the same line of drugs and biological agents will be difficult to recruit patients.

 

It seems reasonable to allow the re-examination period to reach the necessary 3000 cases of re-examination by extending the re-examination period and changing the number of subjects.

 

Meanwhile, if the PMS period of Alumiant is adjusted to 6 years + 35 months, it will end on November 10, 2026.