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Medication passes safety, quality tests
Korea will approve the world’s first stem-cell medication as early as this month, the Korea Food and Drug Administration said Friday.
The state-run drug regulator said Friday that Hearticellgram-AMI, a stem-cell medication for treating heart attack victims, passed all the required safety and quality tests early this week.
It will be the world’s first therapeutic stem-cell solution to be approved.
Patients suffering acute myocardial infarction, commonly known as a heart attack, receive coronary angioplasty, an operation to repair or open a blocked blood vessel.
However, the heart can lose function if its muscle or blood vessels are damaged during the procedure.
The stem-cell medication, if injected into coronary arteries, will help the damaged cells regenerate and recover its function, said the manufacturer, local bio-venture company FCB-Pharmcell.
In the company’s clinical trials over the past six years, patients showed a meaningful improvement in heart function six months after one dose of the injection, the company and KFDA said.
If the safety requirements are met, experts predicted, the medication can be used most effectively by being injected directly into the heart muscle.
“In a bid to give hope to chronically ill patients, we have worked on the drug, pouring about 30 billion won in R&D activities since 2002. We will try harder for its immediate use,” said Kim Hyun-soo, head of the company.
The KFDA plans to complete the approval process within a month of the final phase determining the terms of the drug’s permission renewal, which will come three years after being put to market.
To make the drug, a patients’ bone marrow should be extracted with their consent, and then cultivated in the laboratory for three to four weeks before being injected back into the patient. Except for the cultivation, all the procedures are to be carried out in hospitals.
By Lee Ji-yoon (jylee@heraldcorp.com)
Korea will approve the world’s first stem-cell medication as early as this month, the Korea Food and Drug Administration said Friday.
The state-run drug regulator said Friday that Hearticellgram-AMI, a stem-cell medication for treating heart attack victims, passed all the required safety and quality tests early this week.
It will be the world’s first therapeutic stem-cell solution to be approved.
Patients suffering acute myocardial infarction, commonly known as a heart attack, receive coronary angioplasty, an operation to repair or open a blocked blood vessel.
However, the heart can lose function if its muscle or blood vessels are damaged during the procedure.
The stem-cell medication, if injected into coronary arteries, will help the damaged cells regenerate and recover its function, said the manufacturer, local bio-venture company FCB-Pharmcell.
In the company’s clinical trials over the past six years, patients showed a meaningful improvement in heart function six months after one dose of the injection, the company and KFDA said.
If the safety requirements are met, experts predicted, the medication can be used most effectively by being injected directly into the heart muscle.
“In a bid to give hope to chronically ill patients, we have worked on the drug, pouring about 30 billion won in R&D activities since 2002. We will try harder for its immediate use,” said Kim Hyun-soo, head of the company.
The KFDA plans to complete the approval process within a month of the final phase determining the terms of the drug’s permission renewal, which will come three years after being put to market.
To make the drug, a patients’ bone marrow should be extracted with their consent, and then cultivated in the laboratory for three to four weeks before being injected back into the patient. Except for the cultivation, all the procedures are to be carried out in hospitals.
By Lee Ji-yoon (jylee@heraldcorp.com)
