Lupus drug 'BENLYSTA' opened rehabilitation path

The MFDS manages 'RMP' that does not meet PMS… "Action for the patients"

There is now a way to recover the lupus drug, Benlysta, which is at risk of withdrawal due to failure to meet postmarketing (PMS) criteria.

 

The MFDS decided to use the drug as a RMP (Risk Management Plan) after long discussion of the Central Pharmaceutical Affairs Council and continue to use it for patients to monitor side effects.

 

According to the MFDS on November 28, Benlysta, which PMS expired in June, will be designated as an RMP target and managed.

 

The new drug should submit a monitored use report for more than 3000 patients for six years after marketing.

 

Failure to comply will result in administrative disposition in three stages, and the final product license will be revoked.

 

Although Benlysta is the only biologic formulations used in lupus disease, it has not met the PMS standards due to its high price as a non-reimbursement drug.

 

Moreover, the possibility of failing to fill more than 3000 patients even during the three administrative disposition periods was strong, and in the end, the cancellation of the product license was prominent.

 

However, as the drug is undergoing a reimbursement discussion recently and voiced that the license should be maintained at the request of the patient and the seller, the MFDS discussed it through the Central Pharmaceutical Affairs on the 4th.

 

As a result of the discussion, it was recognized that Benlysta's necessity to maintain licenses was secured in order to secure patient treatment opportunities.

 

Therefore, it was suggested that new measures for safety and effectiveness should be prepared.

 

There were also opinions that it is practically difficult to report 3000 cases of use report through existing drug review.

 

Kyu-han Chae, director of Biopharmaceutical Quality Control department in MFDS, said, "Benlysta is the only biologics of lupus treatment, and the experts have agreed with the necessity of maintaining the license because of its usefulness in patients who have not responded to existing treatment." The MFDS will continue to monitor post-marketing and maintain permits through RMP instead of PMS.

 

RMP is a submission of a risk management plan throughout the life cycle of a drug product, which requires the reporting of evaluation results every six months up to two years after the product approval and once a year after two years.

 

The director, Chae said, "We plan to evaluate the safety and efficacy of post-marketing products according to the characteristics of drugs." Mr.

 

Chae added “ We ordered the company to make a risk management plan so that it could be actively marketed and used to treat patients”.

 

Mr.

 

Chae added that the action was decided to be patient-centered in order to secure patient treatment opportunities.

 

However, Benlysta's initial disposal cannot be avoided.

 

If the new drug fails to submit a usability survey necessary for re-evaluation, the first administrative disposition will suspend the sale of the item for three months.

 

Meanwhile, lupus disease is a chronic autoimmune disease that occurs mainly in young age, including women of childbearing age, and is an inflammatory reaction in the whole body such as skin, joints, kidneys, lungs, and nerves.

 

Over time, symptoms worsen and relieve over time, greatly reducing the quality of life of patients.

 

It is reported that there are about 10,000 lupus patients in Korea.