The UK's Medicines and Healthcare products Regulatory Agency (MHRA) has approved Ronapreve as the first monoclonal antibody therapy specifically designed to combat COVID-19, marking a significant milestone in the country's therapeutic arsenal against the pandemic. The approval coincides with promising trial results from AstraZeneca showing substantial protection for vulnerable populations.
First-in-Class COVID-19 Treatment Approved
Ronapreve, developed jointly by Regeneron and Roche, represents the first treatment of its kind designed specifically to combat COVID-19 in the UK. The therapy combines two monoclonal antibodies in a drug administered by injection or infusion, working by binding to the virus and preventing it from entering the respiratory system.
According to the MHRA, clinical trial data demonstrates that Ronapreve can "prevent infection, promote resolution of symptoms of acute COVID-19 infection and reduce the likelihood of being admitted to hospital due to COVID-19." The regulatory agency began reviewing data on a rolling basis in January 2021, conducting what it described as a "rigorous, scientific and detailed review of all the available data."
Health Secretary Sajid Javid emphasized the treatment's significance, stating: "This treatment will be a significant addition to our armoury to tackle COVID-19 – in addition to our world-renowned vaccination programme and life-saving therapeutics dexamethasone and tocilizumab."
AstraZeneca Reports Strong Prevention Results
On the same day as the Ronapreve approval, AstraZeneca published results from its PROVENT pre-exposure prophylaxis trial, demonstrating that its AZD7442 antibody combination reduced the risk of developing COVID-19 symptoms by 77% compared with placebo.
The analysis encompassed 5,172 study participants who were not infected with COVID-19 at the trial's start. Notably, more than three-quarters of participants had comorbidities that trigger a lower immune response to COVID-19 vaccines, highlighting the treatment's potential value for vulnerable populations.
AstraZeneca described AZD7442 as "the first antibody combination (non-vaccine) modified to potentially provide long-lasting protection that has demonstrated prevention of COVID-19 in a clinical trial." The therapy is administered through intramuscular injection.
Addressing Unmet Medical Needs
Mene Pangalos, executive vice president of biopharmaceuticals R&D at AstraZeneca, highlighted the critical need these treatments address: "We need additional approaches for individuals who are not adequately protected by COVID-19 vaccines. We are very encouraged by these efficacy and safety data in high-risk people, showing our long-acting antibody combination has the potential to protect from symptomatic and severe disease, alongside vaccines."
The MHRA's interim Chief Quality & Access Officer, Dr. Samantha Atkinson, emphasized the thorough evaluation process: "After a meticulous assessment of the data by our expert scientists and clinicians, we are satisfied that this treatment is safe and effective."
Implementation and Future Outlook
The UK government and NHS will determine deployment strategies for Ronapreve "in due course," according to the MHRA. The regulator noted that Ronapreve is not intended as a substitute for COVID-19 vaccination but rather as a complementary therapeutic option.
For AstraZeneca's AZD7442, additional trial data will be released later this year. The company has submitted interim clinical trial reports for Ronapreve, with final study reports expected in coming months, including results from Oxford University's RECOVERY trial.
Both developments represent significant advances in COVID-19 therapeutics, particularly for clinically extremely vulnerable individuals who may not achieve adequate protection from vaccines alone. The approvals underscore the UK's position as a leader in identifying and deploying COVID-19 treatments following rigorous clinical evaluation.
