EMA endorses two monoclonal antibody medicines for COVID-19

The European Medicines Agency (EMA)’s human medicines committee, the Committee for Medicinal Products for Human Use (CHMP), has recommended authorising Ronapreve^™ (casirivimab/imdevimab) and Regkirona (regdanvimab) for COVID-19. Ronapreve and Regkirona are the first monoclonal antibody medicines to receive a positive opinion from the CHMP for COVID-19 and join the list of COVID-19 products that have received a positive opinion since Veklury^® (remdesivir) was recommended for authorisation in June 2020.

The committee recommended authorising Ronapreve 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. Ronapreve can also be used for preventing COVID-19 in people aged 12 years and older weighing at least 40 kilograms. The CHMP also recommended authorising Regkirona for treating adults with COVID-19 who do not require supplemental oxygen and who are also at increased risk of their disease becoming severe. 

In reaching its conclusion, the CHMP evaluated data from studies showing that treatment with Ronapreve or Regkirona significantly reduces hospitalisation and deaths in COVID-19 patients at risk of severe COVID-19.  A main study involving 1,192 patients with COVID-19 who did not require oxygen and were at increased risk of their illness becoming severe showed that treatment with Ronapreve at the approved dose led to fewer hospitalisations or deaths when compared with placebo. Overall, 0.9 percent of patients treated with Ronapreve were hospitalised or died within 29 days of treatment compared with 3.4 percent of patients on placebo.

Another main study looked at the benefits of Ronapreve for prevention of COVID-19 in 100 people who had close contact with an infected household member but did not have COVID-19 symptoms. With Ronapreve, 29 percent of people tested positive and developed symptoms within 14 days of their positive test results compared with 42.3 percent of people who received a placebo.

In regard to Regkirona, a study in 434 patients with COVID-19 showed that the treatment led to fewer patients requiring hospitalisations or oxygen therapy or dying when compared with placebo. Among the patients at increased risk of their illness becoming severe, 3.1 percent of patients treated with Regkirona were hospitalised, required supplemental oxygen or died within 28 days of treatment compared with 11.1 percent of patients on placebo.

The safety profile of both medicines was favourable with a small number of infusion-related reactions, and the CHMP concluded that the medicines’ benefits are greater than their risks for their approved uses. 

The CHMP will now send its recommendations for both medicines to the European Commission (EC) for rapid legally binding decisions.