Regeneron, given to Trump, gets emergency US clearance for Covid-19 therapy

Regeneron Pharmaceuticals Inc. K Antibody Cocktail received an emergency use authorization from US drug regulators for the treatment of early Kovid-19 symptoms, adding to the expanding arsenal of therapies available to physicians.

The treatment given to President Donald Trump after contracting coronavirus in October includes two monoclonal antibodies that target the spike proteins used by the virus to enter cells. Trump was treated with medication by his doctors on a compassionate-use request basis.

“In a clinical trial of patients with covid-19, cacirivimab and imdevimab, administered simultaneously, in the emergency room in high-risk patients after hospitalization or treatment for 28 days for patients with covid-19 The seizures were shown after treatment compared to placebo., “The US Food and Drug Administration said in a statement on Saturday. “The safety and effectiveness of this investigational therapy continue to be evaluated for use in the treatment of Kovid-19.”

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The findings of a trial released by Regeneron in October showed that the drug could help treat patients outside the hospital, reduce virus levels and require further medical care. Earlier results released in September pushed Regeneron officials to reach the US Food and Drug Administration about pursuing the Emergency Use Authority.

The agency said the issuance of the Emergency Use Authority is separate from FDA approval. Its decision comes in the form of American cases, with hospitals and deaths all trending upward. A similar antibody therapy made by Eli Lilly & Co. received emergency approval from the FDA on 9 November.

Commissioner FDA Hahn said in the statement, “The FDA is committed to advancing the country’s public health during this unprecedented epidemic.” “Authorizing these monoclonal antibody therapies can help patients avoid hospitalization and reduce the burden on the health care system.”

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