Regkirona is a medicine used for treating COVID-19 in adults who do not require supplemental oxygen and who are at increased risk of their disease becoming severe. Regkirona contains the active substance Regdanvimab.
Regkirona is given as a single infusion into a vein within 7 days of the start of COVID-19 symptoms; the dose depends on the patient’s body weight.
The medicine can only be obtained with a prescription and should be given in healthcare facilities where patients can be monitored while receiving the infusion and for at least 1 hour afterwards, and where they can be adequately managed in case they develop severe allergic reactions, including anaphylaxis.
The active substance in Regkirona, Regdanvimab, is a monoclonal antibody with activity against SARSCoV-2, the virus that causes COVID 19.
A monoclonal antibody is a type of protein that has been designed to attach to a specific structure ( antigen ).
Regdanvimab has been designed to attach to the spike protein of SARS-CoV-2. When Regdanvimab attaches to the spike protein, the virus is unable to enter the body’s cells.
A main study involving 1,315 patients with COVID-19 showed that Regkirona led to fewer patients requiring hospitalisation or oxygen therapy, or dying, when compared with placebo.
Among the patients at increased risk of their illness becoming severe, 3.1% of patients treated with Regkirona ( 14 out 446 ) were hospitalised, required supplemental oxygen or died within 28 days of treatment compared with 11.1% of patients on placebo ( 48 out of 434 ).
The majority of patients in the study were infected with the original SARS-CoV-2 virus or the Alpha variant; data on the efficacy of Regkirona against some circulating SARS-CoV-2 variants is currently limited.
Infusion-related reactions, including allergic reactions and anaphylaxis, may affect up to 1 in 1,000 people given Regkirona.
Regkirona was shown to be effective at reducing the risk of hospitalisation or death in patients with COVID-19 at increased risk of the disease becoming severe.
The safety profile of Regkirona is considered favourable.
The European Medicines Agency ( EMA ) therefore decided that Regkirona’s benefits are greater than its risks and it can be authorised for use in the European Union. ( Xagena )
Source: EMA, 2021