GC Pharma applies for approval for Covid-19 treatment
The Ministry of Food and Drug Safety said Friday that the company submitted paperwork to start the approval process for GC5131A that day. The screening process will evaulate the drug’s efficacy and safety through internal discussions and advice from external experts, the ministry said in a statement.
If conditional use is approved, GC5131A will be the second Korea-made Covid-19 treatment to get a nod following Celltrion’s antibody treatment CT-P59, or Regkirona, which was approved in February.
The ministry’s decision will come before mid-May, as screening procedures for Covid-19 vaccines and treatments in Korea take 40 days.
GC Pharma completed Phase 2 clinical trials of GC5131A in late December. Like Regkirona, GC5131A could be granted conditional use approval, which means the company conducts and submits Phase 3 clinical trial results afterwards.
GC5131A is a plasma treatment that uses blood from recovered Covid-19 patients. Since December, the drug was allowed emergency use on 44 patients. Permissions are granted in cases when a doctor concludes the unauthorized drug is the only option for a patient. GC5131A was the most requested Covid-19 drug candidate.
BY SONG KYOUNG-SON [email@example.com]