Starting in early 2020, Regeneron scientists rapidly responded to the COVID-19 pandemic by discovering and manufacturing a highly potent, anti-spike antibody cocktail that successfully neutralized many SARS-CoV-2 variants, including Delta.

REGEN-COV is not authorized for pre-exposure prophylaxis for prevention of COVID-19. The FDA has authorized the emergency use of REGEN-COV for the treatment of COVID-19 and the post-exposure prevention of COVID-19 under an Emergency Use Authorization (EUA).

FDA bans Lilly, Regeneron antibody use in COVID-19 patients infected by omicron. The FDA has trimmed the authorization for monoclonal antibodies made by Eli Lilly and Regeneron as recent data suggests they are not effective against the omicron variant currently driving a wave of COVID-19 infections.

We quickly evaluated and selected two potent, complementary antibodies that bound to different, non-overlapping parts of the spike protein of the SARS-CoV-2 virus, thereby blocking the virus's ability to infect healthy cells.

5 • Post-exposure prophylaxis with REGEN-COV (casirivimab and imdevimab) is not a substitute for vaccination against COVID-19. REGEN-COV (casirivimab and imdevimab) is not authorized for pre-exposure prophylaxis for prevention of COVID-19. REGEN-COV has been authorized by FDA for the emergency uses described above.

5 • Post-exposure prophylaxis with REGEN-COV (casirivimab and imdevimab) is not a substitute for vaccination against COVID-19. REGEN-COV (casirivimab and imdevimab) is not authorized for pre-exposure prophylaxis for prevention of COVID-19. REGEN-COV has been authorized by FDA for the emergency uses described above.

Our robust pipeline spans eye diseases, allergic and inflammatory diseases, cancer, cardiovascular and metabolic diseases, neuromuscular diseases, infectious diseases and rare diseases.

Founded and led for 35 years by physician-scientists, Regeneron's unique ability to repeatedly and consistently translate science into medicine has led to numerous FDA-approved treatments and product candidates in development, almost all of which were homegrown in Regeneron's laboratories.

To make monoclonal antibodies, scientists expose a specific type of cell from the immune system to a particular viral protein -- in this case, SARS-CoV-2, the virus that causes COVID-19. They can then design the mAb to target a particular virus or a specific part of the infection process.

There is limited information known about the safety and effectiveness of using REGEN-COV to treat people with COVID-19 or to prevent COVID-19 in people who are at high risk of being exposed to someone who is infected with SARS-CoV-2. REGEN-COV is not authorized for pre-exposure prophylaxis for prevention of COVID-19.

The main adverse effects reported for REGEN-COV were dizziness, nausea, rash, chills, and lymphadenopathy. Whereas flushing, urticaria, anaphylaxis, and pruritus were rarely reported. Mechanism of action of REGEN-CoV for the treatment of SARS-CoV-2.

To view our approved products, including Prescribing Information, please click “Learn More About Our Medicines” above.

• Dupixent ® (dupilumab) U.S. Food and Drug Administration (FDA)
• EYLEA ® (aflibercept)
• AFLIBERCEPT 8 MG.
• U.S. Food and Drug Administration.
• Evkeeza ® (evinacumab)
• Kevzara ® (sarilumab)
• POZELIMAB (REGN3918)

Monoclonal Antibodies to Treat Mild-to-Moderate COVID-19 ACTEMRA® (tocilizumab) (EUA issued June, 24 2021, latest update December 21, 2022). On December 23, 2022, the FDA announced approval of a new indication for ACTEMRA (effective December 21, 2022) to treat hospitalized adult patients with severe COVID-19 illness.