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Posted On: 10/05/2020 2:56:14 PM
Post# of 154879
I happened upon an article in Politico that discusses MABs. No mention of Leronlimab, but there are some points that might be of interest and I pasted some of them below. It was posted on 10/2 and updated on 10/3. Nothing really significant, but I thought Azar's comment on EUA timing (a few weeks to a month or two) was interesting.
The White House’s Operation Warp Speed has thrown its weight and its money behind finding a coronavirus vaccine. That intense focus has come at the expense of the monoclonal antibodies, a potential treatment that could combat Covid-19 outbreaks before and after a safe and effective vaccine is widely available.
But Warp Speed has so far spent less than $1 billion to support the development and manufacturing of three monoclonal antibody treatments, versus almost $10 billion on six vaccines. That choice may have slowed late-stage trials and manufacturing of the laboratory-made antibodies that fight Covid-19. And once monoclonal antibodies are approved, there may be shortages, said experts, including one of the drugmakers.
Janet Woodcock, the long-time senior FDA official who is now head of therapeutics at Warp Speed, said in an interview that the government program does plan to invest in more monoclonal antibody treatments beyond the first trio. If the clinical trial results are strong, the government also will likely purchase doses and provide them to Americans at no cost, the same approach Warp Speed is taking with vaccines, she said.
But if monoclonal antibodies — mAbs, for shorthand — are administered on an outpatient basis, Warp Speed is still working carefully through different scenarios on where these infusions will take place. Warp Speed doesn’t want to mix centers administering cancer treatments with Covid-19 treatments, she noted. And they can’t be given in a setting like a retail pharmacy; it must be a more specialized center.
The FDA could issue emergency use authorizations for antibody treatments anywhere from a few weeks to a month or two from now, HHS Secretary Alex Azar said at a House committee hearing on Friday.
https://www.politico.com/news/2020/10/02/warp...nts-425649
The White House’s Operation Warp Speed has thrown its weight and its money behind finding a coronavirus vaccine. That intense focus has come at the expense of the monoclonal antibodies, a potential treatment that could combat Covid-19 outbreaks before and after a safe and effective vaccine is widely available.
But Warp Speed has so far spent less than $1 billion to support the development and manufacturing of three monoclonal antibody treatments, versus almost $10 billion on six vaccines. That choice may have slowed late-stage trials and manufacturing of the laboratory-made antibodies that fight Covid-19. And once monoclonal antibodies are approved, there may be shortages, said experts, including one of the drugmakers.
Janet Woodcock, the long-time senior FDA official who is now head of therapeutics at Warp Speed, said in an interview that the government program does plan to invest in more monoclonal antibody treatments beyond the first trio. If the clinical trial results are strong, the government also will likely purchase doses and provide them to Americans at no cost, the same approach Warp Speed is taking with vaccines, she said.
But if monoclonal antibodies — mAbs, for shorthand — are administered on an outpatient basis, Warp Speed is still working carefully through different scenarios on where these infusions will take place. Warp Speed doesn’t want to mix centers administering cancer treatments with Covid-19 treatments, she noted. And they can’t be given in a setting like a retail pharmacy; it must be a more specialized center.
The FDA could issue emergency use authorizations for antibody treatments anywhere from a few weeks to a month or two from now, HHS Secretary Alex Azar said at a House committee hearing on Friday.
https://www.politico.com/news/2020/10/02/warp...nts-425649
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