COVID-19 Antibody Cocktail Won’t Be Widely Available Due to Limited Production Capacity, Says Roche
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By HospiMedica International staff writers Posted on 19 Oct 2020 |
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The experimental antibody drug cocktail being developed for the treatment of COVID-19 is unlikely to become widely available as it would be impossible to make enough for everyone who needed it, according to Bill Anderson, drugs chief at Roche Holding AG (Basel, Switzerland).
Currently, Regeneron Pharmaceuticals, Inc. (Tarrytown, NY, USA) is conducting trials of its antibody cocktail, REGN-COV2, which is a combination of two monoclonal antibodies (REGN10933 and REGN10987) and was designed specifically to block infectivity of SARS-CoV-2. REGN-COV2 has been found to be effective in reducing COVID-19 symptoms in rhesus macaques and golden hamsters prior to infection as well as after infection with the SARS-CoV-2 virus. This suggests that REGN-COV2 may offer therapeutic benefits both as a treatment and as a preventative measure for COVID-19.
Regeneron has also submitted a request to the US Food and Drug Administration for an Emergency Use Authorization (EUA) for its investigational antibody combination for COVID-19. If REGN-COV2 proves safe and effective in clinical trials and regulatory approvals are granted, Regeneron will manufacture and distribute it in the US and Roche will develop, manufacture and distribute it outside the US. Presently, there are doses available for approximately 50,000 patients, and Regeneron expects to have doses available for 300,000 patients in total within the next few months.
However, Anderson has now said that despite Roche’s efforts to scale up production of REGN-COV2, the treatment would not be available for everyone who needed it because it was impossible to produce the antibody cocktail for everyone. Anderson said that if the drug cocktail received regulatory approval, both the companies would be able to manufacture only about two million doses annually by the end of next March.
“We’ll never be able to produce enough," said Anderson. “This is clearly part of the answer for the world, not the answer. Hopefully we’ll have vaccines and other therapeutics."
Related Links:
Regeneron Pharmaceuticals, Inc.
Roche Holding AG
Currently, Regeneron Pharmaceuticals, Inc. (Tarrytown, NY, USA) is conducting trials of its antibody cocktail, REGN-COV2, which is a combination of two monoclonal antibodies (REGN10933 and REGN10987) and was designed specifically to block infectivity of SARS-CoV-2. REGN-COV2 has been found to be effective in reducing COVID-19 symptoms in rhesus macaques and golden hamsters prior to infection as well as after infection with the SARS-CoV-2 virus. This suggests that REGN-COV2 may offer therapeutic benefits both as a treatment and as a preventative measure for COVID-19.
Regeneron has also submitted a request to the US Food and Drug Administration for an Emergency Use Authorization (EUA) for its investigational antibody combination for COVID-19. If REGN-COV2 proves safe and effective in clinical trials and regulatory approvals are granted, Regeneron will manufacture and distribute it in the US and Roche will develop, manufacture and distribute it outside the US. Presently, there are doses available for approximately 50,000 patients, and Regeneron expects to have doses available for 300,000 patients in total within the next few months.
However, Anderson has now said that despite Roche’s efforts to scale up production of REGN-COV2, the treatment would not be available for everyone who needed it because it was impossible to produce the antibody cocktail for everyone. Anderson said that if the drug cocktail received regulatory approval, both the companies would be able to manufacture only about two million doses annually by the end of next March.
“We’ll never be able to produce enough," said Anderson. “This is clearly part of the answer for the world, not the answer. Hopefully we’ll have vaccines and other therapeutics."
Related Links:
Regeneron Pharmaceuticals, Inc.
Roche Holding AG
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