- CHMP has completed a review of available data for investigational antibody cocktail casirivimab and imdevimab (REGN-COV2) to be considered for the treatment of confirmed COVID-19
- CHMP scientific opinion supports national decision making within EU states on the use of the antibodies before a formal authorisation is granted during a public health emergency
Roche and Regeneron are collaborating on developing and manufacturing casirivimab and imdevimab;Roche will be responsible for distribution inEurope and other countries outside the US
The CHMP’s scientific opinion (under Article 5(3) of Regulation 726/2004) provides a harmonised, EU-level opinion on the efficacy, quality and safety of casirivimab and imdevimab. This review took place in parallel to the EMA’s ongoing rolling review process, which is used to speed up the formal marketing application assessment of a promising medicine during a public health emergency. Under Article 5(3), the CHMP assessed available data in patients with COVID-19, including data from the REGN-COV2 2067 trial, as well as supportive data from other settings.
“This advice by the CHMP regarding casirivimab and imdevimab is an important step towards addressing the COVID-19 pandemic in the EU,” said
The investigational antibody cocktail of casirivimab and imdevimab continues to be evaluated in clinical trials in multiple settings for COVID-19: in non-hospitalised and certain hospitalised patients, including the open-label RECOVERY trial of hospitalised patients in the
In these exceptional times,
About the CHMP’s review under Article 5(3) of Regulation 726/2004
The intent of the Article 5(3) referral procedure is for the CHMP to develop a harmonised scientific opinion at the EU level on the quality, safety and efficacy of a medicine based on the currently available data. The scientific opinions can then be considered by EU member states when making decisions on the use of medicines at a national level before a formal authorisation is issued.
The review under Article 5(3) of Regulation 726/2004 was requested by the EMA’s Executive Director following preliminary discussions with the COVID-19 EMA pandemic task force (COVID-ETF), which brings together experts from across the European medicines regulatory network to advise on the development, authorisation and safety monitoring of medicines and vaccines for COVID-19.
About casirivimab and imdevimab
Casirivimab and imdevimab is a cocktail of two monoclonal antibodies (also known as REGN10933 and REGN10987, respectively) and was designed by Regeneron scientists to block infectivity of SARS-CoV-2, the virus that causes COVID-19. They evaluated thousands of fully-human antibodies produced by the company's proprietary VelocImmune® mice, which have been genetically modified to have a human immune system, as well as antibodies identified from humans who have recovered from COVID-19.
The two potent, virus-neutralising antibodies that form casirivimab and imdevimab are believed to bind non-competitively to the critical receptor binding domain of the virus's spike protein, which is hypothesised to diminish the ability of mutant viruses to escape treatment and to protect against spike variants that may arise in the human population, as detailed in recent Science publications.
Casirivimab and imdevimab have not been approved by any health authority. In
Casirivimab and imdevimab’s development, manufacturing and clinical trials have been funded in part by the
About Roche’s response to the COVID-19 pandemic
As a leading healthcare company we are doing all we can to support countries in minimising the impact of COVID-19. We have developed a growing number of diagnostic solutions that help to detect and diagnose the infection in patients, as well as providing digital support to healthcare systems, and we continue to identify, develop and support potential therapies which can play a role in treating the disease.
We understand the impact of COVID-19 goes beyond those who contract it, which is why we are working with healthcare providers, laboratories, authorities and organisations to help make sure that patients continue to receive the tests, treatment and care they need during these challenging times. As we learn from the pandemic, we are partnering with governments and others to make healthcare stronger and more sustainable in the future.
Our diagnostics solutions:
Reliable, high-quality testing is essential to help healthcare systems overcome this pandemic. Our portfolio includes:
- a high-volume molecular test to detect SARS-CoV-2, the virus that causes COVID-19, (FDA Emergency Use Authorisation (EUA) and available in countries accepting the CE Mark)
- a SARS-CoV-2 laboratory-based antibody test, aimed at detecting the presence of antibodies in the blood targeting the nucleocapsid (FDA EUA and CE Mark)
- an IL-6 test to assist in identifying severe inflammatory response in patients with confirmed COVID-19 (FDA EUA and CE Mark)
Roche v-TAC, which could help simplify the screening, diagnosis and monitoring of patients with respiratory compromise in the current COVID-19 pandemic- a SARS-CoV-2 rapid antibody test to help determine at the point of care whether a person has been exposed to the virus (CE Mark)
- a rapid antigen test to support in the detection of SARS-CoV-2 at the point of care within 15 minutes (CE Mark)
- a high-volume molecular test to simultaneously detect and differentiate between SARS-CoV-2 and influenza A/B, as the symptoms are similar for both (FDA EUA and CE Mark)
- a second SARS-CoV-2 antibody test, aimed at measuring the spike protein to support vaccination development and complement our existing portfolio
- a point-of-care molecular PCR test that simultaneously detects and differentiates between SARS-CoV-2 and influenza A/B infections to support urgent triage and diagnosis (FDA EUA and CE Mark)
Our research into therapies:
There have been/are a number of clinical trials with an external 3rd party as the sponsor exploring the efficacy and safety of Actemra (tocilizumab) for the treatment of COVID-19 associated pneumonia. COVACTA and EMPACTA, sponsored by
We continue to evaluate the data from the global COVACTA study, which did not meet its primary endpoint as announced on
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