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Almost a year after FDA approval, anti-COVID drug finally available in Israel

On Wednesday of this week, Israel’s Health Ministry announced that the Regeneron monoclonal antibody blend would henceforth be offered to COVID-19 patients considered at high risk of progressing to serious illness.

Regeneron is a combination of two substances, Casirivimab and Imdevimab, that have been found to be significantly effective in preventing mild cases of coronavirus from progressing to serious illness and death.

Monoclonal antibodies are laboratory-made proteins that mimic the immune system’s ability to fight off harmful pathogens. Casirivimab and Imdevimab are specifically directed against the spike protein of COVID-19, designed to block the virus’ attachment and entry into human cells.

The drugs’ effectiveness in combination were confirmed as early as November of 2020 by the FDA, which granted emergency use authorization (EUA) for the treatment of mild to moderate COVID-19 for anyone over the age of 12.

“In a clinical trial of patients with COVID-19, Casirivimab and Imdevimab, administered together, were shown to reduce COVID-19-related hospitalization or emergency room visits in patients at high risk for disease progression within 28 days after treatment when compared to placebo,” the FDA wrote in its statement announcing the EUA.

“The FDA remains committed to advancing the nation’s public health during this unprecedented pandemic. Authorizing these monoclonal antibody therapies may help outpatients avoid hospitalization and alleviate the burden on our health care system,” said FDA Commissioner Stephen M. Hahn, M.D.

The FDA noted that the “data supporting this EUA for Casirivimab and Imdevimab are based on a randomized, double-blind, placebo-controlled clinical trial in 799 non-hospitalized adults with mild to moderate COVID-19 symptoms … For patients at high risk for disease progression, hospitalizations and emergency room visits occurred in 3% of Casirivimab and Imdevimab-treated patients on average compared to 9% in placebo-treated patients.”

In June, 2021, the large RECOVERY trial based in the UK confirmed previous findings, showing that use of Regeneron reduced by 20% the 28-day mortality of people admitted to hospital with COVID-19 whose immune systems had not responded to the virus.

In August, 2021, the FDA expanded its EUA for Regeneron, now available in injection form; previously, it could only be administered by intravenous drip.

According to Ynet, senior medical officials admitted that people “had to know about [Regeneron] to ask for it,” and that “only those who were hospitalized with us [a certain hospital] were able to receive the drug.”

Other anonymous sources quoted by Ynet added that they did not know why the drug was not made available to those in need, though they surmised that the reason could be bureaucratic “struggles.”

Arutz Sheva has approached the Health Ministry for a response and will update accordingly.

Source: Arutz Sheva