We’re excited about COVID-19 vaccines—but there have been major breakthroughs on therapeutics, too, which are important to saving lives in the pandemic. On the latest episode of the I AM BIO Podcast, BIO’s Dr. Michelle McMurry-Heath discussed two of them with Ajay Nirula, Eli Lilly’s VP of Immunology.
There are 580+ COVID-19 therapeutics in development—and they’ll be essential while we wait for vaccines to be approved and distributed. (You can see everything in development at BIO’s COVID-19 pipeline tracker.)
The U.S. Food and Drug Administration (FDA) recently issued emergency use authorization (EUA) for two:bamlanivimab and baricitinib, both developed by BIO member Eli Lilly.
What’s an EUA? It’s a “pragmatic path” for use of a drug during an emergency such as a pandemic, explained Nirula. “Even though you may not have all the data that would serve as the basis for a traditional approval, you have a strong body of data that suggests there could be benefit for a therapy.”
For mild to moderate cases of COVID-19,bamlanivimab is a “highly potent neutralizing antibody” shown to reduce hospitalization rates from 6% to under 2% when given within a few days of the onset of symptoms.
For more serious cases,baricitinib can be used in combination with Gilead’s remdesivir to treat patients with respiratory distress. It’s a repurposed rheumatoid arthritis drug, which Lilly found (using AI) could potentially treat the inflammatory stage of COVID-19.
The company will have 1 million antibody doses available by the end of the year. “Lilly realized that the need was going to be very large globally for antibody therapy if we were able to generate some evidence of efficacy,” said Nirula. “So, we really started significant manufacturing activities at risk much earlier in the year so we could have as much antibody as was feasible” by the time of EUA or approval.
What will 2021 look like? “We’re going to see an evolution where we’ll incorporate some of these scientific advances, which include the great breakthroughs in vaccines that we’re starting to see evidence of, but also the important role that therapeutics will play,” he said.
And in the meantime: “Our behavior is going to continue to be very important over the next year. So, I think we’ve got to be very rigorous in terms of taking the protective measures against spreading the virus, which include continued use of face masks and limiting sizes of gatherings and so forth,” he concluded. “And hopefully by the latter half of 2021, we’ll see a world that’s starting to get back to a little closer to what we’re used to before the pandemic.”
Listen to the whole thing to learn more about the treatments and how Lilly will get them to patients who need them, including the least-developed countries.
Get the episode at www.bio.org/podcast or wherever you get your podcast fix, including Apple, Google, or Spotify.
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