The Korean drug regulator is likely to nullify approval for Yoos Neurosolution (ingredient: ursodeoxycholic acid), a medicine that inhibits the progression of Lou Gehrig’s disease.
However, the canceling of the license will have no impact on patients, as an alternative treatment is available, and no patient is taking the drug, observers said.
|Lou Gehrig’s disease treatment Yoos Neurosolution by Yoos Pharm Korea|
According to the minutes of the Ministry of Food and Drug Safety’s central pharmaceutical affairs advisory committee, the panelists advised the ministry nullify the nod for Yoos Neurosolution.
In 2009, the government approved the drug on the condition that the drug manufacturer conducts a phase-3 trial. The treatment is made from a high-content liquid agent of ursodeoxycholic acid, which is well known as the main ingredient of hepatic protector Ursa.
Drugmaker Yoos Pharm Korea said its Lou Gehrig's treatment is anti-apoptotic and neuroprotective. Without altering the molecular structure of ursodeoxycholic acid, the drug prevents progression of muscle regeneration and improves symptoms by inhibiting apoptosis, the company said.
Although ursodeoxycholic acid was widely well known, physicians rarely prescribed Yoos Neurosolution because it cost as high as 19 million won ($17,053) a year.
Yoos Pharm applied for a phase-3 trial in 2014 but has failed to conduct the study to date.
The ministry asked the pharmaceutical firm to submit the result of the phase-3 trial by June 23, 2018. However, the company requested to extend the deadline until June 23, 2023, without proceeding with the trial.
The members of the central pharmaceutical affairs advisory committee did not accept the company’s request.
Lou Gehrig's disease destroys motor neurons only. Its official name is amyotrophic lateral sclerosis (ALS).
Drugs that can be used to treat Lou Gehrig's disease include Rilutek Tab., Uritek Tab., Radicut Inj., and Nuedexta.