Australia’s TGA provisionally approved Celltrion’s Regkirona® (regdanvimab) for the treatment of adults with coronavirus who do not require supplemental oxygen and are at increased risk of progressing to severe COVID-19.

Celltrion announced that the EC has approved Regkirona® (regdanvimab, CT-P59) for adults with COVID-19 who do not require supplemental oxygen and who are at increased risk of progressing to severe COVID-19.

The CHMP recommended approval of Celltrion’s Regkirona® regdanvimab for the treatment of adults with COVID-19 who do not require supplemental oxygen and who are at increased risk of progressing to severe COVID-19.

Celltrion announced that it has submitted a Marketing Authorisation Application to the EMA seeking approval of regdanvimab for the treatment of COVID-19 in adults who do not require supplemental oxygen therapy and who are at increased risk of progressing to severe COVID-19.

Celltrion announced that South Korea’s MFDS has approved regdanvimab for the extended use in elderly patients aged 50 years and over, or with at least one underlying medical condition with mild symptoms of COVID-19, and in adults patients with moderate symptoms of COVID-19.

Brazil’s ANVISA granted emergency use authorisation (EUA) for Celltrion’s COVID‑19 treatment regdanvimab. 

Inhalon Biopharma announced it will partner with Celltrion to develop IN-006, an inhaled form of regdanvimab for the treatment of COVID-19. It is hoped that the product will be able to reach the virus in the airways and allow patients to self-administer treatment at home. Last week we reported that regdanvimab demonstrated strong neutralising activity against the Delta variant of COVID-19 in pre-clinical studies.

Celltrion announced pre-clinical in vivo studies of CT-P59 (regdanvimab) demonstrated strong neutralising activity against the Delta variant of COVID-19. Celltrion reported a 100% survival rate after a clinically relevant dose compared to 0% for the placebo group, with significant protection against body weight loss after viral challenge. A therapeutic dosage of CT-P59 also significantly reduced the viral load and inflammation in the lungs compared to non-treated controls.