- Two monoclonal antibody medicines for treating COVID-19 have been recommended for authorisation by the European Medicines Agency on Thursday (11 November), sparking new hopes in the fight against the virus.
- “Ronapreve and Regkirona are the first monoclonal antibody medicines to receive a positive opinion from the CHMP for COVID-19,” the agency said in a statement.
- Ronapreve and Regkirona have been authorised in the EU. This follows the granting of marketing authorisations for these products by the European Commission.
EMA Recommends Authorisation of Two Monoclonal Antibody Medicines Ronapreve & Regkirona for Covid-19
EMA’s human medicines committee (CHMP) has recommended authorising Ronapreve (Casirivimab/Imdevimab) and Regkirona (Regdanvimab) for COVID-19.
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 company that applied for authorisation of Ronapreve was Roche Registration GmbH. With regard to Regkirona, the Committee recommended authorising the medicine for treating adults with COVID-19 who do not require supplemental oxygen and who are also at increased risk of their disease becoming severe. The applicant for Regkirona was Celltrion Healthcare Hungary Kft.
The CHMP will now send its recommendations for both medicines to the European Commission for rapid legally binding decisions.
First monoclonal antibodies recommended for marketing authorisation:
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.
Monoclonal antibodies are proteins designed to attach to a specific target, in this case the spike protein of SARS-CoV-2, which the virus uses to enter human cells.
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. Another study showed that Ronapreve reduces the chance of having COVID-19 if a household member is infected with SARS‐CoV‐2, the virus that causes COVID-19.
While the evaluation of the marketing authorisation applications for these medicines was underway, the Committee gave advice to assist EU Member States in deciding on the early use of these medicines. This means the medicines were already available to some patients in the EU.
Study data for Ronapreve:
A main study involving 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 (dummy treatment). 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).
Another main study 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% of people (29 out of 100) who received Ronapreve developed symptoms compared with 42.3% of people (44 out of 104) who received a placebo.
Study data for Regkirona:
A main study in patients with COVID-19 showed that Regkirona 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% 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 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.
More information about the evaluation of both medicines and their approved product information is available on the medicine pages for both medicines on EMA’s website.
Other therapeutics are on the way:
Three COVID-19 treatments are under marketing authorisation evaluation, and three more are under rolling review, including molnupiravir, further boosting healthcare professionals toolkit against the virus.
Molnupiravir, Merck and Ridgeback’s oral COVID-19 antiviral medicine received authorisation in the UK on Thursday (4 November), demonstrating a reduced risk of hospitalisation or death of around 50%.
On Monday (8 November), the EMA announced it was reviewing data on the use of molnupiravir to support national authorities who may decide on using it for COVID-19 treatment before its authorisation.
While the more comprehensive rolling review is ongoing ahead of a possible application for marketing authorisation, EMA’s Committee for Medicinal Products for Human Use (CHMP) will provide EU-wide recommendations to help national authorities use the medicine in emergency use settings.
The decision came as EMA and the Heads of Medicines Agencies (HMA) agreed on the need for additional guidance on COVID-19 treatments in light of rising infection rates and deaths across the EU.
The authorisation in the UK was based on results from a planned interim analysis from the Phase 3 clinical trial, which evaluated Molnupiravir 800 mg twice-daily in non-hospitalised, unvaccinated adult patients. In the interim analysis, 7% of patients who received molnupiravir were either hospitalised or died, compared with 14% of placebo-treated patient.
On Monday (8 November), Reuters reported that The European Union is negotiating with Merck & Co and Pfizer over possible contracts to use their COVID-19 drugs.
Pfizer announced on Friday (5 November) that its novel COVID-19 oral antiviral candidate, PAXLOVID, reduced hospitalisation and death from any cause by 89% compared to placebo in patients treated within three days of symptom onset. No deaths were reported in patients who received PAXLOVID compared to 10 deaths in patients who received a placebo. Less than 1% of patients who received PAXLOVID were hospitalised, compared to 7% of placebo patients who were hospitalised or died.
Reuters reported that Pfizer has yet to submit any data because preliminary results of its trials were published only last week, a month after Merck’s first results