Business & Finance
EMA Issues Advice on Regeneron's Antibody Cocktail for Certain COVID-19 Patients
26 February 2021 - - The European Medicines Agency's Committee for Medicinal Products for Human Use has issued a positive opinion for US-based Regeneron Pharmaceuticals, Inc's (NASDAQ: REGN) investigational COVID-19 antibody cocktail (casirivimab with imdevimab), the company said.

The CHMP recommends that the antibody cocktail, known as REGEN-COV in the US, can be used to treat confirmed COVID-19 in patients who do not require supplemental oxygen and who are at high risk of progressing to severe COVID-19.

The CHMP recommendation provides a harmonized, European Union -level opinion on the efficacy, quality and safety of the antibody cocktail, which can be used by EU member states when making decisions on the possible use of the antibody cocktail at a national level prior to a market authorization.

Under Article 5(3) of Regulation EC 726/2004, the CHMP assessed available data in non-hospitalized patients with COVID-19 as well as supportive data from other settings.

The CHMP's 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.

Once finalized it will be the basis for an EU marketing authorization for the antibody cocktail. Regeneron, together with Roche, continues to work closely with the EMA as it undertakes its rolling review.

Regeneron is collaborating with Roche to increase global supply of the antibody cocktail.

Regeneron is responsible for development and distribution of the treatment in the US, and Roche is primarily responsible for development and distribution outside the US, with the first Roche-manufactured doses already being distributed.

The companies share a commitment to making the antibody cocktail available to COVID-19 patients around the globe and will support access in low- and lower-middle-income countries through drug donations to be made in partnership with public health organizations.

The development and manufacturing of REGEN-COV have been funded in part with federal funds from the Biomedical Advanced Research and Development Authority (BARDA), part of the US Department of Health and Human Services, Office of the Assistant secretary for Preparedness and Response, under OT number: HHSO100201700020C.

The antibody cocktail, known as REGEN-COV (casirivimab with imdevimab) in the US, consists of two monoclonal antibodies (also known as REGN10933 and REGN10987) and was designed specifically to block infectivity of SARS-CoV-2, the virus that causes COVID-19.

The two potent, virus-neutralizing antibodies that form the cocktail bind non-competitively to the critical receptor binding domain of the virus's spike protein, which diminishes the ability of mutant viruses to escape treatment and protects against spike variants that have arisen in the human population, as detailed in Science.

In November 2020, REGEN-COV received Emergency Use Authorization from the US Food and Drug Administration for the treatment of mild to moderate COVID-19 in adults, as well as in pediatric patients at least 12 years of age and weighing at least 40 kg, who have received positive results of direct SARS-CoV-2 viral testing and are at high risk for progressing to severe COVID-19 and/or hospitalization.

The clinical evidence from Regeneron's outpatient trial suggests that monoclonal antibodies such as casirivimab and imdevimab have the greatest benefit when given early after diagnosis and in patients who are seronegative and/or who have high viral load.

The criteria for 'high-risk' patients are described in the Fact Sheet for Healthcare Providers. In the US, REGEN-COV is not authorized for use in patients who are hospitalized due to COVID-19 or require oxygen therapy, or for people currently using chronic oxygen therapy because of an underlying comorbidity who require an increase in baseline oxygen flow rate due to COVID-19.

REGEN-COV continues to be evaluated in clinical trials in multiple settings for COVID-19: in non-hospitalized and certain hospitalized patients, including the open-label RECOVERY trial of hospitalized patients in the UK, and a trial for the prevention of COVID-19 in household contacts of infected individuals.

As of February 2021, approximately 23,000 people have participated in clinical trials involving REGEN-COV.

Lower doses of REGEN-COV are also being studied with the aim of increasing the number of patients who could potentially be treated if the cocktail is approved.

REGEN-COV was invented using Regeneron's VelocImmune technology that utilizes a proprietary genetically engineered mouse platform endowed with a genetically-humanized immune system to produce optimized fully-human antibodies.