5 out of 11 COVID-19 trials approved to speed up development

MFDS “Stocked up enough Kaletra and hydroxychloroquine for COVID-19 treatment”

Apparently, total 11 clinical trials in patients with COVID-19 have applied for the Korean health authority’s approval and five of them were cleared.

 

The Korean government says pharmaceutical companies have sufficient stock of Kaletra and hydroxychloroquine used to treat COVID-19.

 

On Mar.

 

27, Ministry of Food and Drug Safety (MFDS, Minister Lee Eui-kyung) officials reported the ministry is supporting rapid development of COVID-19 treatment and vaccine while managing stable supply of drugs used to treat patients with COVID-19.

 

According to MFDS, it has formed ‘Commercialization Team’ under the COVID-19 Risk Management Support Headquarter on Feb.

 

3 to provide individual consulting for companies engaged in development of COVID-19 treatment and vaccine, and to expedite and prioritize the clinical trial review procedure.

 

So far, 11 COVID-19-related clinical trial review applications have been submitted, and five of them were approved after consulting with experts from Korea Society of Infectious Disease (KSID) and Korean Society for Antimicrobial Therapy (KSAT).

 

Currently, three clinical protocols using Gilead Sciences’ Ebola treatment remdesivir, one protocol with HIV-1 treatment Kaletra plus malaria treatment hydroxychloroquine and another protocol with hydroxychloroquine only have been approved for COVID-19.

 

The ministry has also reportedly approved six cases of using clinical drugs under investigation as influenza treatment to treat COVID-19, and the ministry is continuing to review ten other cases.

 

The six cases of using ImmuneMed’s HzVSF for treatment purpose have been approved at Seoul National University Hospital, Yeungnam University Medical Center, and Chungnam National University Hospital.

 

Treatment-purpose approval allows MFDS to grant approval on using an unapproved investigational drug for urgent patients either with life-threatening condition or without alternative treatment.

 

MFDS has informed Korea Association of Institutional Review Board (KAIRB) about expedited clinical trial with ‘considerations related to clinical trials on COVID-19.’ The consideration talks about Institutional Review Board (IRB) prioritizing clinical protocol review related to COVID-19, allowing video conference for deliberation, and asking for the trial participant’s consent via phone call.

 

And MFDS official added the ministry would actively cooperate with Ministry of Science and ICT (MSIT) and Korea Centers for Disease Control and Prevention (KCDC) on the COVID-19 treatment development project to shorten the development period as much as possible.

 

The project would mediate sharing information regarding clinical trial protocol from the initial stage and assessing scientific evidences to minimize error in the study.

 

At the moment, MSIT is operating Pharmaceutical Rediscovery Project to explore and inform the medical industry of an effective medicine against COVID-19, out of drugs approved by the U.S.

 

Food and Drug Administration (FDA), and to push on with the candidate medicine’s clinical trial.

 

KCDC is currently running a research on clinical trial regarding expanding indications on approved drugs, antibody and plasma-derived therapies and vaccines to treat patients with COVID-19.

 

Besides various efforts to drive forth clinical trials for the treatment, the ministry stated HIV-1 protease inhibitor drug Kaletra, currently unapproved in Korea, has been exceptionally imported three times to treat patients with COVID-19, upon KCDC’s request.

 

Moreover, the ministry is apparently monitoring supply of Kaletra and hydroxychloroquine used against COVID-19 in Korea to prepare import or production on demand.

 

As of Mar.

 

26, pharmaceutical companies in Korea have stocked Kaletra tablets for about 15,000 patients and hydroxychloroquine tablets for about 200,000 patients.

 

MFDS official stressed, “The Korean government intends to actively aid companies to promptly develop COVID-19 treatment vaccine, and to maintain stable supply of drugs used for COVID-19 by closely cooperating with KCDC and related government agencies.”