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Tags: fda | gottlieb | merck | covid | pill

Former FDA Commissioner Gottlieb: Merck Pill 'a Game Changer'

Former FDA Commissioner Gottlieb: Merck Pill 'a Game Changer'

(Kena Betancur/Getty)


 

By    |   Friday, 01 October 2021 01:04 PM EDT

Former Food and Drug Administration Commissioner Scott Gottlieb said Friday that news Merck would seek emergency use for its antiviral pill to fight COVID-19 offered "a profound game changer" in trying to end the pandemic.

Merck earlier in the day announced that its experimental COVID-19 pill reduced hospitalizations and deaths by half in people recently infected with coronavirus. The company said it soon would ask health officials in the U.S. and around the world to authorize its use.

"This is a phenomenal result," Gottlieb told CNBC. "This is a profound game changer, to have an oral pill that had this kind of effect, this magnitude of effect in patients who are high risk, already symptomatic.

"There's every expectation, based on just how this drug works, that if you moved it earlier in the line of care, on patients maybe who are exposed and aren't symptomatic yet, and patients who aren't as great risks, you're going to see even a greater result. So, this is quite profound."

Gottlieb expressed great optimism for Merck’s drug -- which if approved would be the first pill shown to treat COVID-19 -- partly due to the Ridgeback Biotherapeutics husband-and-wife team of Wendy and Wayne Holman.

"[They] were the team that invented the first successful antibody against Ebola, that was highly successful," Gottlieb said. "So, this is a very good drug development, drug-hunting team that was behind this therapeutic care."

Gottlieb mentioned that two other drugs -- one by Pfizer and one by Roche -- also are in advanced development.

"We might have multiple therapeutics that can be taken at home to prevent COVID disease," said Gottlieb, who is on the Pfizer board

The side effects in human trials of the Merck-Ridgeback Biotherapeutics pill "looked pretty clean" for a drug that will be taken for a relatively short period of time, Gotlieb said.

"You're not going to be taking this drug for six months, or 12 months," he said. "You're going to be taking it for 5 days, perhaps even shorter if it’s used in post-exposure prophylaxis.

"Typically, if you're taking something over a very short-term administration, the safety profile is generally pretty good."

Asked how the use of Regeneron, a combination of two types of monoclonal antibodies. compared to the Merck pill. Gottlieb said the two drugs target "very different mechanisms, so you could even use them together."

"If you have a high-risk patient who comes into the hospital with COVID disease, with a lot of symptoms and risk factors, you may use this drug and the monoclonal antibody and get an even more efficacious effect from the drugs in combination," he said.

The Associated Press contributed to this story.

© 2022 Newsmax. All rights reserved.


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Former Food and Drug Administration Commissioner Scott Gottlieb said Friday that news Merck would seek emergency use for its antiviral pill to fight COVID-19 offered "a profound game changer" in trying to end the pandemic.
fda, gottlieb, merck, covid, pill
445
2021-04-01
Friday, 01 October 2021 01:04 PM
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