Regeneron applied to Food and Drug Administration on August 7, 2020 for emergency authorization for its experimental monoclonal antibody therapy. If successful, then the drug could feature in an emergency to diagnose, treat, or prevent serious or life-threatening disease. Therefore if Regeneron asks for emergency use authorization and gets it, this would speed up supply of the drug.
Regeneron Asks for Emergency Use Authorization in Terms of Agreement
However, Regeneron does have an existing agreement with the U.S. Government according to CNN Health. Assuming the emergency use authorization is granted, then government will pay for the drug, and its distribution in terms of this. Moreover Regeneron currently has sufficient doses on hand for 25,000 COVID-19 patients. But this number will increase six times ‘within the next few months’.
Regeneron is asking for emergency use authorization while its monoclonal antibody treatment is still in large scale-trials. It is therefore currently only available for compassionate use, if the Food and Drug Administration agrees that:
1… ‘The patient has a serious disease or condition, or whose life is immediately threatened by their disease or condition’
2… ‘There is no comparable or satisfactory alternative therapy to diagnose, monitor, or treat the disease or condition’
What the Regeneron Drug Is Intended to Achieve
The Regeneron drug REGN-COV2 is a ‘cocktail’ of two or more antibodies developed in a laboratory, and then cloned. First, one monoclonal antibody targets the spike protein the coronavirus uses to enter healthy human cells. Then the second antibody reduces the viral load.
Regeneron CEO Dr. Leonard Schleifer told CNN in a recent interview ‘This class of drugs is an extremely safe class’. However Dr. Richard Besser, former acting director of the CDC is more cautious. ‘I would withhold judgement of this until I see the data from the large-scale trials’, he advises.
Related
U.S. Clinical Trials of Monoclonal Antibodies
Vital Clue to the Extent of US COVID-19
Preview Image: Cells that Make Monoclonal Antibodies
Regeneron Press Release September 29, 2020
Related FDA Policies
1… FDA Policy on Compassionate Use
