Regeneron Asks FDA to Approve Emergency Use of REGN-COV2 for COVID-19

Source: FirstWord

Regeneron Pharmaceuticals said that it submitted a request to the FDA seeking emergency-use authorization for its REGN-COV2 investigational antibody combination for the treatment of COVID-19. REGN-COV2 is a combination of two monoclonal antibodies, REGN10933 and REGN10987, which has been designed to block infectivity of SARS-CoV-2.

The disclosure came the same day that Eli Lilly announced that it submitted an EUA request to the FDA for its neutralising IgG1 monoclonal antibody LY-CoV555 for use in higher-risk patients who have been recently diagnosed with mild-to-moderate COVID-19.

Available in US at no cost

According to Regeneron, under an agreement with the US government, if an EUA is granted, the government has committed to making REGN-COV2 available to the American people at no cost and would be responsible for its distribution. The company noted that currently there are doses available for approximately 50,000 patients, while it expects to have doses available for 300,000 patients in total within the next few months.

Regeneron reported early study results last month showing that the addition of REGN-COV2 to standard-of-care reduced viral load as well as the time to symptom alleviation in non-hospitalised patients with COVID-19. Meanwhile, the company more recently confirmed that a single 8g dose of REGN-COV2 was given to President Donald Trump following a compassionate-use request from his doctors as part of a treatment regimen also including Gilead Sciences’ antiviral Veklury (remdesivir) and the steroid dexamethasone.

Trump touts REGN-COV2

Following treatment and amid his ongoing recovery from COVID-19, Trump said REGN-COV2 was “the key” to his positive outcome. “I want everybody to be given the same treatment as your president,” he remarked, adding that “I think we’re going to work it so you’re going to get [REGN-COV2 and LY-CoV555] and you’re going to get ’em free,” with distribution handled by the military.

Further, Trump’s doctor said that a recent blood test showed that the president had detectable levels of SARS CoV-2 antibodies, which had not been present in a test prior to receiving REGN-COV2. Regeneron noted that it is not possible for the blood test to distinguish between antibodies made by Trump himself and those from REGN-COV2. ┬áCompany spokeswoman Alexandra Bowie said that given the volume of antibodies delivered in REGN-COV2, and the timing of the tests, “it is likely that the second test is detecting REGN-COV2 antibodies.”

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