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GC Pharma to apply for COVID-19 plasma therapy EUA in April
By Lim Jeong-yeoPublished : Jan. 20, 2021 - 14:50
Drug maker GC Pharma will apply to expedite the use of its plasma-derived COVID-19 treatment in April in Korea, the company said on Wednesday.
The plasma therapy, GC5131A, which uses donated blood plasma from recovered COVID-19 patients, targets those infected who display serious symptoms.
In the previous year, the company had said on multiple occasions that it anticipates to release the drug in the market within the first quarter of 2021.
The company only wrapped up administration of the therapy on 64 patients enrolled in its phase 2a clinical trial as of January.
Once the gathered data goes through analyzation by March, GC Pharma will submit an application with the Ministry of Food and Drug Safety for immediate use of the therapy at medical forefronts, or what is called an emergency use of authorization, according to the company’s chief development officer Lee Jae-woo, who spoke at a National Assembly discussion event on Jan. 12.
The company’s 2a trial, co-designed with the state-run Korea National Institute of Health, is a “prospective, open-label, randomized, multi-center, phase 2a study to evaluate the dose response, efficacy and safety of the hyperimmune globulin GC5131 in patients with COVID-19,” the company said.
While clinical 2a trials are often conducted to find the right dosing requirement, and follow-up clinical 2b trials are to discern the efficacy of the dose, GC Pharma will bypass the 2b trial and directly proceed to application for emergency use.
The press relations official at the GC Pharma told The Korea Herald that the process abides by the research agreements with the government authorities.
Notwithstanding the lagged progress towards emergency use authorization, GC5131A has earned therapeutic use authorization for COVID-19 at 31 hospitals in the country as of Jan. 15.
A therapeutic use authorization is when each individual medical institute seeks the Drug Ministry’s nod for a so-far unapproved drug’s clinical use. This can be granted when there is no other known treatment to save a gravely ill person.
By Lim Jeong-yeo (kaylalim@heraldcorp.com)
The plasma therapy, GC5131A, which uses donated blood plasma from recovered COVID-19 patients, targets those infected who display serious symptoms.
In the previous year, the company had said on multiple occasions that it anticipates to release the drug in the market within the first quarter of 2021.
The company only wrapped up administration of the therapy on 64 patients enrolled in its phase 2a clinical trial as of January.
Once the gathered data goes through analyzation by March, GC Pharma will submit an application with the Ministry of Food and Drug Safety for immediate use of the therapy at medical forefronts, or what is called an emergency use of authorization, according to the company’s chief development officer Lee Jae-woo, who spoke at a National Assembly discussion event on Jan. 12.
The company’s 2a trial, co-designed with the state-run Korea National Institute of Health, is a “prospective, open-label, randomized, multi-center, phase 2a study to evaluate the dose response, efficacy and safety of the hyperimmune globulin GC5131 in patients with COVID-19,” the company said.
While clinical 2a trials are often conducted to find the right dosing requirement, and follow-up clinical 2b trials are to discern the efficacy of the dose, GC Pharma will bypass the 2b trial and directly proceed to application for emergency use.
The press relations official at the GC Pharma told The Korea Herald that the process abides by the research agreements with the government authorities.
Notwithstanding the lagged progress towards emergency use authorization, GC5131A has earned therapeutic use authorization for COVID-19 at 31 hospitals in the country as of Jan. 15.
A therapeutic use authorization is when each individual medical institute seeks the Drug Ministry’s nod for a so-far unapproved drug’s clinical use. This can be granted when there is no other known treatment to save a gravely ill person.
By Lim Jeong-yeo (kaylalim@heraldcorp.com)
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