Oxiracetam and Acetyl-L-Carnitine
All Related Indications Deleted
Choline Alfoscerate Also Undergoing Benefit Reduction
Market Expansion Movement for Ginkgo Leaf with Blood Circulation Improvement Effects
[Asia Economy Reporter Lee Chun-hee] Drugs known as brain function enhancers are facing a series of harsh setbacks as they repeatedly fail to prove their efficacy. As indications for degenerative diseases related to cerebrovascular conditions are either completely rejected or significantly reduced, expectations for a rebound effect on drugs that still maintain their effectiveness are conversely increasing.
According to the related industry on the 18th, on the 16th, the Ministry of Food and Drug Safety (MFDS) issued a drug information letter recommending the suspension of prescription and dispensing for six products containing the ingredient 'Oxiracetam,' produced by four companies, stating that it failed to prove effectiveness in improving symptoms of vascular cognitive impairment.
Despite clinical results submitted by the manufacturers confirming symptom improvement, the MFDS's own review and consultation with the Central Pharmaceutical Review Committee concluded that effectiveness for the related symptoms was not proven. Oxiracetam had already failed to prove efficacy for the indication of Alzheimer's dementia, and with the deletion of the indication for improving symptoms of vascular cognitive impairment, all its efficacies have disappeared.
In addition to Oxiracetam, brain function enhancers have recently faced painful experiences such as deletion of efficacy, leading to their removal from the reimbursement market, marking a harsh saga. In August last year, following a re-evaluation of clinical trials, the MFDS stopped prescriptions and dispensing of Acetyl-L-Carnitine, stating it failed to prove efficacy for 'secondary degenerative diseases caused by cerebrovascular disease.' Since the indication for primary degenerative diseases was deleted in 2019, all efficacies of Acetyl-L-Carnitine disappeared, and all remaining drugs were recalled and destroyed. Despite boasting a market size exceeding 50 billion KRW annually, the market itself vanished in an instant.
Consequently, expectations are rising that Choline Alfoscerate, which holds the indication for 'secondary symptoms and degenerative or degenerative brain organic mental syndrome caused by cerebrovascular defects,' and Ginkgo biloba extract, which holds the indication for 'treatment of organic brain dysfunction accompanied by dementia symptoms such as memory decline, concentration disorder, depression, and dizziness,' will enjoy a significant rebound effect.
In the case of Choline Alfoscerate, Daewoong Bio’s 'Gliatamine' recorded prescription sales of 115.6 billion KRW, and Chong Kun Dang’s 'Chong Kun Dang Gliatilin' recorded 97.4 billion KRW last year, boasting a market size of about 500 billion KRW. The sales volume of the drug surged, leading it to be included in the 'usage-price linkage negotiation' for drug price reduction.
However, concerns remain that Choline Alfoscerate cannot be a long-term solution. This is because its reimbursement recognition was reduced through a 2020 re-evaluation, but related lawsuits have continued, temporarily halting the reduction of reimbursement. At that time, the government maintained reimbursement for Alzheimer's dementia due to confirmed efficacy but applied selective reimbursement for other cognitive improvements, raising the patient’s co-payment rate up to 80% due to insufficient evidence. However, the court ruled in favor of the government in the first instance of the administrative lawsuit, and considering that it is sold as a health functional food ingredient in the US and Europe, the industry widely expects that maintaining reimbursement for Choline Alfoscerate will be difficult.
Ginkgo biloba extract is sold under SK Chemicals’ 'Ginexin' and Yuyu Pharma’s 'Tanamin.' It has proven therapeutic effects on dementia symptoms such as memory decline and concentration disorder through blood flow improvement and blood circulation effects. Although it is an over-the-counter drug, it can also be taken by prescription, and recently pharmaceutical companies have shown growing interest in Ginkgo biloba extract as they seek to explore markets to replace existing brain function enhancers.
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