The Ministry of Food and Drug Safety has decided to allow limited use of Gemvax & KAEL's Riavax, an Alzheimer's disease drug candidate, on Alzheimer's patients who had received the treatment in previous clinical trials.
The ministry decided so after it discussed the appropriateness of using Riavax for therapeutic purposes at the Central Pharmaceutical Affairs Council.
Riavax, which received conditional approval as a treatment for pancreatic cancer in 2015 on condition of conducting a phase 3 clinical trial, had its license revoked by the ministry in August last year after it had failed to submit a clinical result report despite the expiration of the conditional approval period.
In the process, Gemvax also conducted clinical trials on Alzheimer's patients, with the phase 2 clinical trial approved and completed in 2016. The company also submitted an investigational new drug application to conduct a phase 3 study for the drug this year.
Against this backdrop, the ministry discussed whether it is possible to use Riavax for therapeutic purposes for Alzheimer's patients. The ministry found it necessary to re-examine the appropriateness of Riavax’s use because it had canceled the product approval due to an unclear mechanism of action and the company’s failure to prove the treatment's efficacy.
The council members acknowledged the necessity of using Riavax because Riavax had completed phase 2 clinical trial and had no severe adverse reactions, and the drug showed anti-inflammatory action, although the company failed to provide a clear mechanism.
However, a majority said the company should limit the study to patients who had received the treatment in previous clinical trials or therapeutic use, citing that the phase 2 study alone was insufficient and that there would be large fluctuations in the examination for patients with moderate to severe Alzheimer's disease.
The council also addressed whether the drug candidate is suitable to target Alzheimer's disease.
According to the Pharmaceutical Affairs Act, drug candidates can target patients whose life is imminently endangered without therapy and for patients whose treatment effect is difficult to expect if they miss their treatment timing and have no alternative treatment methods.
In conclusion, the council said that Alzheimer's disease could be a therapeutic target for Riavax. Still, it limited the drug use for Alzheimer's disease patients who had previously used the drug, according to the ministry.