Telcon RF Pharmaceutical-KPM Tech Apply for FDA Emergency Use Authorization of Humangen COVID-19 Treatment in the US

[Asia Economy Reporter Yoo Hyun-seok] The COVID-19 treatment drug for which Telcon RF Pharmaceutical and KPM Tech secured the distribution rights is on the verge of receiving usage approval.

According to Telcon RF Pharmaceutical and KPM Tech on the 31st, Humanigen applied for Emergency Use Authorization (EUA) from the U.S. Food and Drug Administration (FDA) for Lenzilumab on the 28th (U.S. local time) as a COVID-19 treatment.

Humanigen stated, "Lenzilumab can save lives," and added, "In a situation where COVID-19 continues to spread despite vaccination, it can meet the demand for effective treatment."

Lenzilumab is a new drug candidate that treats the immune overreaction caused by the cytokine storm, a major cause of death from COVID-19. Clinical trials were simultaneously conducted on 520 patients in the U.S. and Brazil and completed last March.

Phase 3 results showed that Lenzilumab increased survival without ventilation (SWOV) by 92% compared to patient groups treated with the previously approved COVID-19 treatments Remdesivir and corticosteroids. It also improved by 54% compared to the placebo group.

Telcon RF Pharmaceutical and KPM Tech secured the domestic and Philippine distribution rights for Lenzilumab from Humanigen in November last year.

A representative from Telcon RF Pharmaceutical said, "If Lenzilumab obtains FDA emergency use approval, we have been promoting bridging clinical trials since January to enable rapid domestic use," and added, "Although vaccination has started, the number of COVID-19 patients in Korea remains high at around 500, so we expect that the introduction of Lenzilumab will minimize COVID-19 damage."

This content was produced with the assistance of AI translation services.