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Ronapreve based on Casirivimab and Imdevimab in adults and adolescents for treating or preventing COVID-19


Ronapreve is a medicine used for treating COVID-19 in adults and adolescents ( from 12 years of age and weighing at least 40 kilograms ) who do not require supplemental Oxygen and who are at increased risk of their disease becoming severe.
The medicine can also be used to prevent COVID-19 in people aged 12 years and older weighing at least 40 kilograms.
Ronapreve contains two active substances, Casirivimab and Imdevimab.

Ronapreve is given as a single treatment by infusion into a vein or by injection under the skin.
The recommended dose is 600 mg of Casirivimab and 600 mg of Imdevimab.
When used for treatment, it should be given within 7 days of the patient developing symptoms of COVID-19.

When used for prevention after contact with a person with COVID-19, Ronapreve should be given as soon as possible after contact occurred. Ronapreve may also be given to prevent COVID-19 when no contact has occurred. In these cases, following an initial dose of 600 mg Casirivimab and 600 mg Imdevimab, a dose of 300 mg of Casirivimab and 300 mg of Imdevimab may be given every four weeks until prevention is no longer required.

The medicine can only be obtained with a prescription and should be given in healthcare facilities where patients can be adequately monitored and managed in case they develop severe allergic reactions, including anaphylaxis.

Casirivimab and Imdevimab are two monoclonal antibodies. A monoclonal antibody is a type of protein that has been designed to recognise and attach to a specific structure ( an antigen ). Casirivimab and Imdevimab have been designed to attach to the spike protein of SARS-CoV-2 at two different sites. When the active substances attach to the spike protein, the virus is unable to enter the body’s cells.

Treatment of COVID-19

A main study ( COV-2067 ) involving patients with COVID-19 who did not require oxygen and were at increased risk of their illness becoming severe showed that Ronapreve at the authorised dose led to fewer hospitalisations or deaths when compared with placebo.
Overall, 0.9% of patients treated with Ronapreve ( 11 out of 1,192 patients ) were hospitalised or died within 29 days of treatment compared with 3.4% of patients on placebo ( 40 out of 1,193 patients ).

Prevention of COVID-19

A main study ( COV-2069 ) looked at the benefits of Ronapreve for prevention of COVID-19 in people who had close contact with an infected household member.
Ronapreve was found to be effective at preventing people from getting infected and developing symptoms after contact: amongst people who tested negative for SARS-CoV-2 following contact, fewer people given Ronapreve developed symptoms within 29 days of their test results compared with people given placebo ( 1.5% [ 11 out of 753 ] for Ronapreve compared with 7.8% [ 59 out of 752 people ] for placebo ).
Ronapreve was also found to be effective at preventing symptoms in infected people. Amongst the people who tested positive for SARS-CoV-2 after contact, 29% ( 29 out of 100 ) of people who received Ronapreve developed symptoms compared with 42.3% ( 44 out of 104 people ) of people who received a placebo.

Risks associated with Ronapreve

The most common side effects with Ronapreve ( which may affect up to 1 in 10 people ) are allergic reactions, which include infusion related reactions and injection site reactions.

Ronapreve has shown a clinically meaningful effect in preventing hospitalisation and death in patients with COVID-19, while also showing benefits in preventing COVID-19.
Although vaccination is the main way of preventing COVID-19, there is an unmet medical need in people who have been exposed to COVID19 as well as in people who cannot be vaccinated and who require long-term prevention.
The safety profile of Ronapreve is favourable.
The European Medicines Agency decided that Ronapreve’s benefits are greater than its risks. ( Xagena )

Source: EMA, 2021

XagenaMedicine_2021



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