FDA Expands Emergency Use Authorization for REGEN-COV to Include Post-Exposure Prophylaxis of COVID-19

Currently, the COVID-19 pandemic outside China continues to spread rapidly. According to Baidu's "Real-Time Big Data Report on the Novel Coronavirus Pneumonia Epidemic", as of 12:00 on July 31, 2021, the global cumulative number of confirmed cases has exceeded 198 million (198.01 million), with deaths exceeding 4.22 million.

Recently, Regeneron announced that the U.S. Food and Drug Administration (FDA) has updated the Emergency Use Authorization (EUA) for the COVID-19 antibody cocktail therapy REGEN-COV (casirivimab and imdevimab). The authorization now includes: post-exposure prophylactic treatment for individuals at high risk of progressing to severe COVID-19, who are not fully vaccinated or are expected not to mount an adequate immune response to vaccination, have been exposed to an individual infected with SARS-CoV-2, or are at high risk of exposure due to infections occurring within the same institutional setting (such as nursing homes or prisons).

For individuals requiring repeat dosing due to ongoing exposure, REGEN-COV can now be administered once monthly. This new indication for individuals aged 12 years and older supplements the prior authorization for the treatment of non-hospitalized COVID-19 patients. REGEN-COV cannot replace vaccination against COVID-19 and is not authorized for pre-exposure prophylaxis to prevent COVID-19.

Notably, REGEN-COV is the only COVID-19 antibody therapy in the United States authorized for both treatment and post-exposure prophylaxis. REGEN-COV retains efficacy against multiple variants of concern. Currently, the use of REGEN-COV in the United States is rapidly increasing to address the ongoing COVID-19 pandemic.

This authorization update is supported by data from a pivotal Phase 3 clinical trial (REGN-COV 2069). The trial demonstrated that among close contacts (household members) of SARS-CoV-2-infected individuals, a single subcutaneous dose of REGEN-COV reduced the risk of symptomatic COVID-19 infection by 81%.

REGEN-COV Antibody Cocktail

Dr. George D. Yancopoulos, President and Chief Scientific Officer of Regeneron, stated: “Today’s FDA authorization, which allows certain individuals at high risk of developing severe COVID-19 to receive REGEN-COV treatment following exposure to the virus, marks the first authorization of an antibody therapy for this purpose. Under this authorization, the FDA has specifically emphasized the needs of immunocompromised populations, including those taking immunosuppressive medications who may have an inadequate immune response to vaccination, as well as individuals who have been exposed to someone with COVID-19 or are at high risk of exposure due to an infection occurring within the same institutional setting. Today’s FDA decision to expand the use of REGEN-COV in the post-exposure setting is a highly beneficial step, and we will continue to collaborate with the FDA as the agency reviews REGEN-COV for broader populations, including for pre-exposure prophylaxis in immunocompromised individuals and for patients hospitalized with COVID-19.”

Experts estimate that approximately 3% of the U.S. population may have an inadequate immune response to COVID-19 vaccination due to immunocompromise or immunosuppressive medications. This includes patients receiving chemotherapy, those with hematologic malignancies such as chronic lymphocytic leukemia, individuals undergoing stem cell transplantation or hemodialysis, organ transplant recipients, and/or patients taking certain medications that may attenuate the immune response (e.g., mycophenolate, rituximab, azathioprine, anti-CD20 monoclonal antibodies, and Bruton tyrosine kinase [BTK] inhibitors). This authorization enables the use of REGEN-COV for post-exposure prophylaxis in these populations and in certain institutional settings.

Under the EUA for post-exposure prophylaxis, REGEN-COV may be administered via subcutaneous injection or intravenous infusion. For individuals who are not expected to mount an adequate immune response following vaccination and who have ongoing exposure to SARS-CoV-2 for more than 4 weeks, following an initial dose of 1,200 mg, REGEN-COV may be administered at a dose of 600 mg every 4 weeks during the period of ongoing exposure.

Antibodies attacking a virus (Image source: europeanpharmaceuticalreview.com)

REGEN-COV is an antibody cocktail therapy co-developed by Roche and Regeneron, with Roche primarily responsible for its development and supply outside the United States. REGEN-COV consists of two monoclonal antibodies (casirivimab and imdevimab) that target two distinct, non-overlapping epitopes within the receptor-binding domain of the novel coronavirus (SARS-CoV-2) spike (S) protein. These antibodies exert a synergistic effect, reducing the risk of viral mutational escape and protecting the population against viral variants harboring mutations in the S protein. Furthermore, data from preclinical studies indicate that casirivimab and imdevimab retain neutralizing activity against key emerging variants.

This July, REGEN-COV (brand name: Ronapreve) received the world’s first approval in Japan, for administration via intravenous infusion to treat patients with mild-to-moderate COVID-19. In addition to Japan, REGEN-COV has currently been authorized for emergency use or temporary pandemic authorization in more than 20 countries worldwide, including the United States, the European Union, India, Switzerland, and Canada. In the European Union, the European Medicines Agency (EMA) is conducting a rolling review of the REGEN-COV antibody cocktail therapy, and its Committee for Medicinal Products for Human Use (CHMP) has issued a positive scientific opinion supporting REGEN-COV as a treatment option for patients with confirmed COVID-19 who do not require supplemental oxygen and are at high risk of progressing to severe COVID-19.

In the United States, REGEN-COV was granted Emergency Use Authorization (EUA) by the FDA in November 2020 for the treatment of pediatric and adult patients aged ≥12 years and weighing ≥40 kg with mild to moderate COVID-19 who have tested positive on a direct SARS-CoV-2 viral test and are at high risk of progressing to severe COVID-19 and/or hospitalization. REGEN-COV should be administered via intravenous (IV) infusion; subcutaneous (SC) injection is an alternative when IV infusion is not feasible and would result in a delay in treatment.

Following the updated U.S. FDA authorization, for post-exposure prophylaxis, REGEN-COV 1200 mg (600 mg casirivimab + 600 mg imdevimab) may be administered via subcutaneous injection (4 injections) or intravenous infusion (in as little as 20 minutes). For individuals who are not expected to mount an adequate immune response to vaccination and who have ongoing exposure to SARS-CoV-2 for more than 4 weeks, after an initial dose of 1200 mg, REGEN-COV 600 mg may be administered every 4 weeks during the period of continued exposure. (Bioon.com)

Original Source: FDA Expands Authorized Use of REGEN-COV™ (casirivimab and imdevimab)

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