Filenews 12 November 2021
The EMA's Committee for Medicinal Products for Human Use (CHMP) recommended the authorisation of Ronapreve (casirivimab/imdevi mab) and Regkirona (regdanvimab) for COVID-19.
The Commission recommended that Ronapreve be authorised to treat COVID-19 in adults and adolescents (aged 12 and over with a body weight of at least 40 kg), who do not need additional oxygen and who are at increased risk of developing their disease into a serious one.
Ronapreve can also be used to prevent COVID-19 in people aged 12 years and older weighing at least 40 kg. The company that applied for ronapreve's licensing is Roche Registration GmbH.
As regards Regkirona, the Commission recommended authorising the medicine to treat adults with COVID-19 who do not need additional oxygen and who are also at increased risk of developing their disease condition into a serious one. The applicant for Regkirona was Celltrion Healthcare Hungary Kft.
The CHMP will now forward its recommendations on the two medicines to the European Commission for the swift adoption of legally binding decisions.
The first monoclonal antibodies are recommended for marketing authorisation
Ronapreve and Regkirona are the first monoclonal antibodies to receive a positive recommendation from the CHMP for COVID-19 and are included in the list of products against COVID-19 that have received a positive recommendation since Veklury (remdesivir) was set up for licensing in June 2020.
Monoclonal antibodies are proteins designed to adhere to a specific target, in this case the spike protein of the SARS-CoV-2 virus, which the virus uses to enter human cells.
To reach its conclusion, the CHMP evaluated data from studies showing that treatment with Ronapreve or Regkirona significantly reduces hospitalization and deaths in COVID-19 patients at risk of severe COVID-19 disease. Another study showed that Ronapreve reduces the likelihood of developing COVID-19 disease if a member of the same housekeeping house has contracted SARS‐CoV‐2, the virus that causes COVID-19.
While the evaluation of marketing authorisation applications for these medicines was ongoing, the Committee issued recommendations to help EU Member States decide on the early use of these medicines. This means that medicines were already available to some patients in the EU.
Study data for Ronapreve
A main study involving COVID-19 patients who did not need oxygen and who were at increased risk of their disease's condition developing into severe, showed that treatment with Ronapreve at the approved dose led to fewer hospitalizations or deaths compared to placebo (a dummy treatment). Overall, 0.9% of patients treated with Ronapreve (11 out of 1,192 patients) were hospitalized or ended up within 29 days of treatment, compared with 3.4% of patients treated with placebo (40 out of 1, 193 patients).
Another main study looked at the benefits of Ronapreve for the prevention of COVID-19 disease in people who had close contact with an infected housekeeping member but had no symptoms of COVID-19 disease. With Ronapreve, 29% (29 out of 100) of people tested positive for the COVID-19 virus and developed symptoms within 14 days of the day they were diagnosed, compared to 42.3% (44 out of 104 people) of people taking placebo.
Study data for Regkirona
A main study in patients with COVID-19 disease showed that treatment with Regkirona resulted in fewer patients who needed hospitalization or oxygen therapy or ended up compared to placebo. Among patients at increased risk of developing their disease condition to severe, 3.1% of patients taking Regkirona (14 out of 446) were hospitalized, needed supplemental oxygen or ended up within 28 days of treatment compared to 11.1% of patients taking placebo (48 out of 434).
The safety profile of both drugs was favourable with a small number of infusion-related reactions and the CHMP concluded that, for their approved uses, the benefits of the drugs are greater than their risks.
More information on the evaluation of the two drugs as well as the approved product information is available on the EMA's website on the respective pages of the two medicines.
