The Food and Drug Administration Antimicrobial Drugs Advisory Committee Meeting voted on Tuesday to recommend authorizing the molnupiravir Covid pill from Merck for high-risk adults. It would be the first in a new class of antiviral drugs that could work against a wide range of variants, including Omicron.
Molnupiravir has been shown to modestly reduce the risk of hospitalization and death, predominantly from the Delta, Mu and Gamma variants. The expert panel recommended it for Covid patients who are older or have medical conditions that make them vulnerable to severe illness. The pill could be authorized in the United States within days, and available by year’s end.
Next up for the F.D.A. is voting on a similar pill from Pfizer. Initial results that appears that this pill appears to be significantly more effective than Merck’s.
Potential Against Omicron
Omicron is the latest variation of major concern. Significantly given there are pills, unlike the vaccines the pills do not target the spike protein. The FT reported “The 50 mutations on the new B.1.1.529 variant… include more than 30 on the spike protein, the exposed part of the virus that binds with human cells. These changes could make it more transmissible than the dominant Delta variant and more likely to evade the immune protection conferred by vaccines or prior infection.” Some of those mutations may make it hard for vaccine-produced antibodies to attack the virus.
The pills however do not target the spike protein. Instead, they weaken two proteins involved in the virus’s replication machinery. Omicron carries only one mutation in each of those proteins, and neither looks as if it would stop the pills from doing their jobs.
In a presentation to the committee members, Daria Hazuda, a Merck executive, said molnupiravir’s activity is similar across known variants and that the drug works in a way that makes it likely to be active against new variants.
Another Merck executive, Dr. Nicholas Kartsonis, told the panel on Tuesday that the company is “feverishly working” to collect samples from people infected with Omicron that it can use in laboratory studies to help determine whether the drug will work against the variant.Via New York Times
In a clinical trial, molnupiravir was found to reduce by 30 percent the risk of hospitalization or death when given to high-risk, unvaccinated volunteers within five days after they started showing symptoms. This is substantially less effective than Pfizer’s pill, which was found to lower risk by 89 percent, and monoclonal antibody treatments, which have been found to cut it by at least 70 percent.
If molnupiravir is authorized, U.S. supply is expected to be limited at first, though it will be more abundant than Pfizer’s pill. The Biden administration has ordered enough courses of treatment, at about $700 per person, for 3.1 million people. Merck is expected to supply those pills before February.
The treatment is given within five days of the start of symptoms and is taken as 40 pills over five days. To get the pills, people will moat likely need to test positive for the virus soon after they start showing symptoms. However it often takes several days to get results from a P.C.R. test.
Molnupiravir, sold under the brand name Lagevrio, is an antiviral medication that inhibits the replication of certain RNA viruses, and is used to treat COVID-19 in those infected by SARS-CoV-2. Molnupiravir is a prodrug of the synthetic nucleoside derivative N⁴-hydroxycytidine and exerts its antiviral action through introduction of copying errors during viral RNA replication.
Molar mass: N-Hydroxy-5′-O-isobutyryl-3,4-dihydrocytidine, [(2R,3S,4R,5R)-3,4-Dihydroxy-5-[4-(hydroxyamino)-2-oxopyrimidin-1-yl]oxolan-2-yl]methyl 2-methylpropanoate (PIN)3D model (Jmol):Interactive image
Trade names: Lagevrio
Source: November 30, 2021 FDA
From The TradersCommunity News Desk