The government granted emergency authorization for Actemra (ingredient: tocilizumab) to treat Covid-19 infection.

However, the Ministry of Food and Drug Safety (MFDS) said Actemra is indicated for critically ill Covid-19 patients and will not replace Celltrion’s Regkirona (regdanvimab), which is used for mild and moderate Covid-19 infection.

The regulator authorized the emergency use of Actemra for the treatment of seriously ill Covid-19 patients.
The regulator authorized the emergency use of Actemra for the treatment of seriously ill Covid-19 patients.

On Tuesday, the MFDS announced that it gave emergency use approval for Actemra to treat seriously ill Covid-19 patients aged two or older. It is used for hospitalized Covid-19 patients receiving systemic corticosteroids who require supplemental oxygen.

Actemra, developed by Chugai Pharmaceutical under the Roche Group, is an intravenous injectable autoimmune disease treatment. In Korea, the treatment obtained marketing approval for the treatment of rheumatoid arthritis. JW Pharmaceutical has the exclusive rights to develop and market Actemra in the local market.

The emergency authorization came at the request of the Korea Disease Control and Prevention Agency (KDCA). The MFDS granted the permit for Actemra to prevent a shortage of Covid-19 treatments amid a spiking number of Covid-19 cases, it said.

The MFDS reviewed Actemra using cases in other countries, clinical trial papers, and advice from infectious disease specialists. Then, it went through a review by the Public Health Risk Responding Healthcare Products Safety Management and Supply Committee and determined to grant the emergency license to Actemra.

The treatment became reimbursable in March.

With the latest approval for Actemra, JW Pharmaceutical came under the spotlight in the stock market. Shares of JW Pharmaceutical once shot up to a 52-week high at 31,900 won on Tuesday.

On Tuesday morning, just before the announcement of the emergency authorization, Hanyang Securities released a report on JW Pharmaceutical to highlight the sales growth potential of Actemra.

As the government decided not to supply the nation’s only Covid-19 treatment Regkirona anymore, marketing approval for Actemra is expected to have a substantial impact on the stock market,” Hanyang Securities said in the report. “Under the circumstance that Covid-19 cases shot up to hundreds of thousands daily, Actemra, which costs hundreds of thousands won per injection, could add earnings significantly.”

An official at the MFDS cautioned against an outlook for an expanded supply of Actemra.

“Actemra’s indication is different from Regkirona’s. Regkirona is to prevent mild and moderate Covid-19 patients from progressing to a serious disease, and Actemra is authorized to treat seriously ill patients,” the official said.

Actemra suppresses the cytokine storm, so it will be effective to treat infection with the Omicron variant, too, he added.

Copyright © KBR Unauthorized reproduction, redistribution prohibited