Regkirona gets conditional use approval in Australia

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Regkirona gets conditional use approval in Australia

Published: 07 Dec. 2021, 16:04

Celltrion’s Regkirona, the first homegrown Covid-19 treatment [CELLTRION]

Regkirona, Korea’s first Covid-19 treatment, won conditional use approval from regulators in Australia, manufacturer Celltrion said Tuesday.

The target is high-risk adults who were infected with the coronavirus and show slight and moderate symptoms, according to Australia’s Therapeutic Goods Administration.

Australia has seen a growing number of infections recently.

So far, Regkirona has received formal marketing approvals from Korea’s Ministry of Food and Drug Safety and the European Commission. Brazil and Indonesia issued emergency-use authorizations, while Peru granted conditional use approval.

Phase 3 trials showed that Regkirona slows the progression rate of the disease by 70 percent, and by 72 percent for high-risk patients over 50 or those with underlying conditions.

Celltrion has been conducting Phase 1 clinical trials of an inhalable form of Regkirona in Australia in collaboration with Durham, North Carolina-based Inhalon Biopharma. The inhalable form will allow for the conveying of the treatment directly into the airways using an inhaler, Celltrion said.

BY SARAH CHEA [chea.sarah@joongang.co.kr]