• Monoclonal drugs in high demand for severe COVID-19 infections; supply issues a concern

    Posted on Oct 8, 2021

    Regeneron’s antibody cocktail for treatment of COVID-19 infection (REGEN-COV, comprised of monoclonals casirivimab and imdevimab) was approved by the FDA in October 2020 for mild-to-moderate disease in SARS-CoV-2-positive pediatric and adult patients (including seniors) at high risk for progressing to severe COVID-19. In May 2021 the FDA lowered the threshold for its “unhealthy weight” criterion and included race and ethnicity as factors, expanding the potential pool of eligible patients to an estimated 75% of American adults. In June 2021, the FDA increased the ease of REGEN-COV administration by approving injection rather than infusion of the antibody cocktail.

    With the surge of Delta variant infections in the US unvaccinated population, usage of REGEN-COV has increased dramatically. Based on Phase 3 data demonstrating a >80% reduction in the risk of symptomatic infections following close contact with SARS-CoV-2-infected individuals, the FDA recently expanded authorization of REGEN-COV to prophylactic use in persons known to have been exposed to an infected individual and even those simply at high risk of exposure in institutional settings such as prisons and nursing homes.

    REGEN-COV sales booming in 2021

    As a result of all these factors, sales of the successful treatment are soaring. Regeneron reported nearly $2.6B in REGEN-COV sales alone in Q2 2021 versus just over $2.53B for sales of all its products in the previous quarter. Although the treatment is provided free to Americans at high risk of developing severe disease, the US pays Regeneron $2,100 per dose for the treatment, with more than 600,000 doses having been administered to date. This number is likely to increase rapidly, as sales are accelerating. After averaging fewer than 25,000 doses/week, the company said that it had delivered >50,000 doses during the last week of July and >100,000 doses the first week of August, reaching 135,000 doses in the second week of the month.

    Another factor driving REGEN-COV’s success is the FDA’s decision in June to pause distribution of competitor Eli Lilly’s COVID-19 antibody cocktail therapy, because it proved to be ineffective against coronavirus variants identified in Brazil and South Africa. Lilly’s drug, approved in late 2020, was initially favored over Regeneron’s for being less expensive, with the result that sales of Lilly’s cocktail came in at $810M in Q1 2021 compared with $439M for Regeneron. However, as a result of the FDA pause, sales in Q3 2021 are now likely to be zero.

    The burgeoning orders for REGEN-COV have raised concerns over whether the company’s supply of the leading COVID-19 treatment is sufficient. While Regeneron recently reported that their current supply is still “ample,” the company expressed that inventory could be exhausted by year’s end. However, the company is planning further manufacturing in the near term and expressed confidence about meeting the growing demand for their drug.

    Critical shortage of Roche’s Actemra

    A more serious supply issue has arisen with another drug commonly used to treat seriously ill COVID-19 patients. Actemra (tocilizumab) from Roche/Genentech is a monoclonal originally approved as a treatment for rheumatoid arthritis that blocks the IL-6 receptor. Rather than attacking the virus directly like REGEN-COV, Actemra, used in conjunction with corticosteroids, works to counteract the cytokine storm that can be the actual cause of death with COVID-19 complications.

    Doctors in China had initially proposed the treatment regimen in early 2020. Actemra received emergency use authorization (EUA) from the FDA in June 2021 as a COVID-19 treatment for patients who require some form of oxygen support. However, increased levels of hospitalizations driven by the Delta variant has led to a global shortage of Actemra that could worsen in the weeks ahead. Created largely by SARS-CoV-2 infections in the voluntarily unvaccinated, this shortage unfortunately also impacts patients who need the drug for its originally approved indications.

    Orders surging for GSK’s monoclonal for severe COVID-19

    Another monoclonal for treatment of severe COVID-19 infections, sotrovimab from GlaxoSmithKline and Vir Biotechnology, received its EUA from the FDA in late May 2021. Despite currently lacking a supply deal with the US federal government, orders for sotrovimab were reportedly up 300% in August versus July of this year based on availability in just 26 states. Sotrovimab works by binding to the SARS-CoV-2 spike protein to prevent the virus from entering additional cells.

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