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.
The EMA’s human medicines committee (CHMP) has recommended authorising Ronapreve and Regkirona to treat COVID-19 in adults and adolescents who do not require supplemental oxygen and are at increased risk of the infection becoming severe.
These are the first monoclonal antibody medicines to receive a positive opinion from the CHMP for COVID-19. They will be added to the list of COVID-19 products that have received a positive opinion since Veklury (remdesivir) in June 2020.
While vaccines play a crucial role in the fight against COVID-19, therapeutics are needed to limit the need for hospitalisation, speed up recovery times, reduce mortality and alleviate lasting symptoms, or long COVID.
The Commission’s strategy on COVID-19 therapeutics was adopted in May 2021, aiming to authorise two COVID-19 therapeutics by October 2021 and possibly two more by the end of the year.
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.
The study data for Ronapreve showed that less than 1% of patients treated with Ronapreve were hospitalised or died within 29 days of treatment compared with 3.4% of patients who took a placebo.
Another study looked at the benefits of Ronapreve for the prevention of COVID-19 in people who had close contact with an infected household member but did not have COVID-19 symptoms. With Ronapreve, 29% of people tested positive and developed symptoms within 14 days of their positive test results compared with 42% who received a placebo.
The study data for Regkirona showed that among patients at increased risk of their illness becoming severe, 3% of patients treated with Regkirona were hospitalised, required supplemental oxygen or died within 28 days of treatment compared with 11% of patients on a 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 more significant than their risks for their approved uses.
While evaluating the marketing authorisation applications for these medicines was underway, the Committee advised assisting EU Member States in deciding on the early use of these medicines. This means the medication was already available to some patients in the EU.
The CHMP will now send recommendations for both medicines to the European Commission for rapid, legally binding decisions.
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 patients.
EU is negotiating with Pfizer
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.