MFDS Approves Korea's First COVID-19 Antibody Treatment 'Rekkirona-ju' (Update)

Conditional Approval Granted by Final Inspection Committee on This Day

[Image source=Yonhap News]

[Asia Economy Reporter Kim Ji-hee] The Ministry of Food and Drug Safety (MFDS) has conditionally approved Celltrion's COVID-19 antibody treatment, "Rekkironaju." This marks the birth of the first domestic COVID-19 treatment drug. Rekkironaju is expected to be used for high-risk mild COVID-19 patients and moderate patients going forward.

On the morning of the 5th, the MFDS held a final review committee meeting for COVID-19 treatments and announced that it decided to grant conditional marketing approval for Rekkironaju on the premise of submitting Phase 3 results after marketing. The final review committee is the last of three expert advisory stages. Previously, the verification advisory group recommended approval of Rekkironaju for mild and moderate patients, but the second stage, the Central Pharmaceutical Affairs Deliberation Committee, limited mild patients to high-risk groups. The final review committee reached the same conclusion as the Central Pharmaceutical Affairs Deliberation Committee.

At a briefing that day, Kim Kang-lip, head of the MFDS, said, "The final review committee comprehensively examined the contents of the two previous advisory meetings and decided to approve the product on the condition of submitting Phase 3 clinical trial results," adding, "After in-depth review of safety and efficacy by field and investigation results, it was judged that there is no problem with product approval."

Accordingly, the administration target is limited to high-risk mild or moderate patients. High-risk groups refer to those aged 60 or older or those with one or more underlying conditions such as cardiovascular disease, chronic respiratory disease, diabetes, or hypertension. Moderate cases include patients with pneumonia symptoms or clinical symptoms and those observed radiologically. The dosage and administration involve intravenous injection of 40 mg of Rekkironaju per 1 kg of adult body weight over 90 minutes (±15 minutes).

Director Kim stated, "We expect the drug to be effective for high-risk mild and moderate patients rather than severe patients," and added, "In cases with a slightly higher risk, such as chronic diseases, mild patients with underlying conditions like diabetes or hypertension, this drug is expected to reduce the risk of progression to severe illness."

Thus, Rekkironaju has become the first domestically developed drug approved for COVID-19 treatment. It is also the third COVID-19 antibody treatment worldwide to be verified by regulatory authorities.

Meanwhile, Celltrion has already begun Phase 3 clinical trials aiming to recruit 1,172 mild and moderate patients in more than 10 countries worldwide. Through this, they plan to reconfirm the safety of Rekkironaju and secure statistical significance regarding its efficacy.

A Celltrion official stated, "We will do our best to supply Rekkironaju nationwide as quickly as possible to significantly shorten the COVID-19 treatment period for our people and minimize the occurrence of severe patients that could lead to death."