The clinical re-evaluation deadline for the dementia treatment drug "choline alphoscerate" has been extended. This measure considers the difficulties pharmaceutical companies are facing in recruiting patients due to conflicts in the medical field following the COVID-19 pandemic.
According to the pharmaceutical and bio industry on the 25th, the Ministry of Food and Drug Safety has reportedly extended the clinical re-evaluation deadline for choline alphoscerate, which is being conducted by companies including Chong Kun Dang and Daewoong Bio, during the Central Pharmacy Review Committee held on the 12th.
Choline alphoscerate was previously used as a brain function enhancer, but due to controversies over its efficacy, the Ministry of Food and Drug Safety has initiated a clinical re-evaluation to prove its efficacy again as of 2021. Pharmaceutical companies must demonstrate the efficacy of choline alphoscerate for mild cognitive impairment by March next year and for Alzheimer's disease by December next year. Currently, among the eight countries that South Korea refers to for drug pricing policies, seven, excluding Italy, classify choline alphoscerate as a health functional food rather than a drug.
Pharmaceutical companies must re-prove the efficacy of choline alphoscerate through clinical re-evaluation. If they fail to demonstrate efficacy during the re-evaluation, they must return 20% of the reimbursements received for choline alphoscerate-based dementia treatments over the past five years. If domestic pharmaceutical companies fail to pass the re-evaluation, the amount to be recovered is expected to reach billions of won.
However, pharmaceutical companies are facing delays in patient recruitment necessary for clinical re-evaluation due to prolonged conflicts between the medical community and the government over increasing the medical school enrollment. Citing this reason, the companies requested an extension of the clinical re-evaluation deadline from the Ministry of Food and Drug Safety. The Ministry accepted this request, agreeing to extend the ongoing mild cognitive impairment clinical trial by Chong Kun Dang by 15 months and the Alzheimer's disease clinical trial by Daewoong Bio by 24 months.