Merck is awaiting FDA approval for its Corona drug. Will she get it?

by time news

When the corona hits again there are those who are making big profits: vaccine maker stocks, such as Moderna and Biontech soared on Friday and Monday, following the emergence of the new Omicron variant. But in stark contrast, the drug giant


MERCK & COMPANY
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(MRK) Absolutely not – and it fell last Friday by 3.8% and yesterday by another 5.8%, when yesterday the S&P 500 made a rebound and rose by 1.5%.

Today the company’s stock is stepping on the spot at a price of $ 74.8. But is she likely to get good news?

While the world is troubled by the emergence of the corona virus omicron variant, a panel of advisers and experts from the Food and Drug Administration (FDA) is expected to convene to discuss granting emergency approval for its anti-coronary drug, which helps relieve disease symptoms in its early stages and prevent hospitalization.

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What is special about the drug, and who else has applied for a similar approval?
It is the first antiviral drug of its kind, for which the drug giant Merck and its partner Ridgeback Biotherapeutics are responsible. Tahin were the first of these commissions on oral corona medication to introduce trials from the third phase of clinical trials, with both companies hoping to be effective against a wide range of corona virus variants.

The drug is called Molnupiravir The FDA’s expert committee will have to vote on whether to recommend the drug’s approval to high-risk patients. The treatment, which according to the companies, has been shown to moderately reduce the risk of hospitalization and mortality, especially from the delta versions of the virus, can be approved in the United States within a few days and available soon after treatment if the committee approves the drug.

At the same time in Europe, the European Medicines Agency, the EMA (the equivalent of the US FDA) has also begun to examine the issue. Mark’s drug was already approved in the UK earlier this month, and it is the first approval for the drug in the world, and it is currently being tested by other countries on the continent.

Mark herself expects to produce 10 million Molnofiravir pills by the end of 2021, and believes its profit from the treatment will stand at about $ 5-7 billion by 2022, including $ 0.5-1 billion expected in 2021, with only one month left until the end of the year.

Will the new drug be effective against the Omicron variant?
Health care systems around the world are building on the new treatments as those that will succeed in reducing the number of serious cases and saving lives. If the omicron causes an increase in serious infections, it can make them even more relevant.

Scientists have not yet conducted experiments to see how much the pills block the culture of the Omicron variant but there are reasons to think they will be effective even if the version can sometimes ‘slip’ from the vaccines currently on the market.

It is currently known that the omicron variant has more than 30 mutations on top of the spike protein that attaches to human cells. Some of these mutations may make it difficult for antibodies produced by the vaccine to attack the virus.

The advantage of the pills is that they are not targeting the spike protein. Instead, they weaken two proteins involved in the replication mechanism of the virus. Omicron carries only one mutation in each of these proteins, and none of them seem to prevent the pills from doing their job.

Merck’s drug reduces the chance of hospitalization or death by 30%
According to a clinical trial conducted by Mark, her treatment was found to reduce by 30% the risk of hospitalization or death when given to high-risk and unvaccinated volunteers within five days after they began to show symptoms. Treatment is given within five days of the onset of symptoms and about 40 pills are taken over five days.

However, it appears to be significantly less effective than Pfizer’s pill, which was found to reduce the risk by 89%, and antibody treatments, which were found to cut it by at least 70%.

And back to the soup, while in the experimental group the hospitalization rate was 7% with no deaths, in the control group it was 14% with eight deaths. No serious side effects were reported. For the trial, 775 patients were recruited in 170 countries, including the United States, Japan, South Africa, Italy and more.

In fact, the experiment was supposed to take longer, however the data already obtained from it after 29 days led to the recommendation of an independent committee to contact the FDA already at this stage and expedite the procedure. The U.S. Food and Drug Administration itself has been encouraged to do so as well.

The great news is actually in the method of administering the drug – other corona drugs are still available today, such as the recent regeneration in the shadow of criticism began to give it more widely in the country to advanced corona patients, or alternatively Giliad’s Remedies (GLD) which Corona patients are treated worldwide. , Although not developed at all for the virus, when it should be noted that in this medical community it is still controversial.

And yet the question arises as to whether a swallowing drug for corona is to some extent not a substitute product for vaccination as further rounds will be required due to a decrease in antibodies or insufficient protection against new variants. It is not inconceivable that some will prefer to take a pill (certainly if it is effective) and would start over taking another vaccine.

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