Celltrion COVID-19 Treatment, Countdown to Market Approval Begins

MFDS to Release Expert Advisory Results on 'Rekkirona Injection' on 27th
Final Decision Expected Early Next Month

CT-P59, an antibody treatment for COVID-19 developed by Celltrion [Image source=Yonhap News]

[Asia Economy Reporter Lee Chun-hee] Celltrion's novel coronavirus disease (COVID-19) antibody treatment 'Rekkirona-ju (CT-P59)' will undergo the second expert advisory procedure by the Ministry of Food and Drug Safety (MFDS) on the 27th. Among the five COVID-19 vaccines and more than three treatments scheduled to be introduced this year, Rekkirona-ju is expected to receive the first approval.

The MFDS will hold a Central Pharmaceutical Affairs Deliberation Committee meeting in the afternoon to seek expert advice on the safety, efficacy, and considerations for approval of Rekkirona-ju. The results will be disclosed on the same day.

Before approving COVID-19 vaccines and treatments, the MFDS conducts a three-tier advisory review process involving the Verification Advisory Group, the Central Pharmaceutical Affairs Deliberation Committee, and the Final Inspection Committee. In the previously held Verification Advisory Group meeting, the efficacy of Rekkirona-ju was recognized, but additional verification was deemed necessary, recommending conditional approval by the MFDS on the premise of conducting phase 3 clinical trials.

Specifically, the advisory group judged that Rekkirona-ju has clinical symptom improvement efficacy and effectiveness for 'mild to moderate adult patients aged 18 and over' who have an oxygen saturation level exceeding 94% in indoor air, do not require supplemental oxygen supply, and whose symptoms appeared within 7 days before administration. In particular, the symptom recovery period was shortened by 3.43 days to 5.34 days with Rekkirona-ju administration compared to 8.77 days in the placebo group. However, the period for conversion from positive to negative was considered clinically insignificant, and the effect on mortality was unknown.

Kim Kang-lip, head of the MFDS, stated at the MFDS business plan briefing on the 25th, "If there are no issues in all review procedures, we expect a final decision on the first domestic treatment early next month."

Previously, the advisory group suggested the prescription recommendation target for Rekkirona-ju as mild to moderate COVID-19 confirmed patients aged 18 and over who participated in phase 2 clinical trials. It is highly likely that final marketing approval will be granted under these conditions.

Celltrion has already completed production of 100,000 doses and is awaiting approval. It plans to obtain emergency use authorization from the U.S. Food and Drug Administration (FDA) and the European Medicines Agency (EMA) by July.