Wednesday, January 19, 2022

New Data Shows Merck’s Experimental COVID-19 Pill Is Less Effective Than Early Results Predicted

Drugmaker Merck and partner Ridgeback Biotherapeutics released data on Friday showing their experimental pill for treating COVID-19 is less effective than early clinical trials predicted, a discovery that came after the Food and Drug Administration and drug administration has raised questions about the drug.

Molnupiravir, a pill that can be taken at home, has shown promising reductions in the risk of hospitalization and death by half among high-risk patients, according to data released by the company in October. But according to the latest data presented by Merck to the FDA, the pill reduced the risk of hospitalization and death by only 30%.

A study by drug manufacturers found that among the participants who received the pill, only one participant died during the trial, compared with nine deaths in the placebo group, the company said in a news release on Friday.

“It’s still a 30% effect, which is still good for a high-risk population,” said David Bowlvar, an infectious disease physician and professor of medicine at the University of Minnesota School of Medicine who was not involved in Merck’s research. “It’s better than zero and it’s a starting point, but it’s a little more modest.”

More on the COVID-19 pandemic

The FDA on Friday asked a panel of expert consultants to weigh the benefits of reduced hospitalizations and deaths in high-risk patients against the potential risks associated with the drug. As Merck and Ridgeback provided the agency with new clinical trial data after FDA scientists completed their review, regulators said their analysis could change ahead of Tuesday’s meeting to review the drug’s scientific evidence.

“As such, the review and benefit / risk assessment questions may differ from the original assessments presented in the white paper, which was based on the interim analysis,” the FDA’s white paper says.

Merck and Ridgeback are seeking emergency approval for their COVID medication, which will be the first easy-to-use pill to fight the virus. The FDA advisory committee is expected to make a recommendation on Tuesday, and agency officials usually follow the advisors’ direction.

The agency reviewed the data provided by the companies and determined that the clinical trial showed no “significant safety issues” associated with side effects. The most common side effects were mild to moderate diarrhea, nausea, and dizziness. However, the FDA has identified several areas of concern, including potential risks to pregnant women and the possibility that the drug could cause the coronavirus to mutate.

The FDA’s Antimicrobial Advisory Committee is due to meet on Tuesday to review the scientific evidence for molnupiravir and weigh how the drug can be used safely to prevent severe infections.

The FDA may authorize the use of the drug to treat patients at increased risk of hospitalization or death due to age or underlying medical conditions such as obesity and heart disease. The agency’s review suggests that regulators may restrict the use of the drug to pregnant, hospitalized and vaccinated people.

The Merck tablet works by interfering with an enzyme that the coronavirus needs to replicate itself and altering the genome of the virus.

Unlike existing therapies, including monoclonal antibodies and the antiviral drug remdesivir, molnupiravir could be prescribed to patients and taken at home without direct medical supervision.

High-risk patients with COVID-19 would start taking the pill within five days of the onset of symptoms and continue to use the drug twice a day for five days. Ease of use can make treatment a powerful tool for preventing worst-case outcomes, preventing moderately ill COVID patients from getting worse and ending up in hospital.

While the drug may play a role in reducing the death toll from the pandemic that has killed more than 775,000 people in the United States, it is not a magic bullet. Some of the study participants, all of whom were not vaccinated and believed to be at high risk of serious infection, ended up in the hospital with complications related to covid.

An FDA review suggests that the pill will not be recommended for patients who are already sick enough to be hospitalized.

Since this medicine is not a perfect medicine, experts emphasize that people still need to get vaccinated to prevent serious COVID infections.

The pill also carries potential risks, especially for pregnant women. Merck did not include pregnant participants in its clinical trials, and required participants who could become pregnant to use contraception while taking the drug. This reflects concerns that the antiviral drug could interfere with the healthy development of the fetus by interfering with the genes of the virus.

The FDA has proposed several ways to limit the intake of the drug to pregnant women because of the risk of birth defects and other potential problems.

“One approach is not to allow [molnupiravir] for use during pregnancy because there are no clinical scenarios in which the benefits outweigh the risks, ”the agency said in its review.

A less restrictive approach would be to provide information on the risks and not recommend pills during pregnancy, but would allow doctors to prescribe the drug “as they see fit in certain clinical scenarios where the benefits were thought to outweigh the risks.”

FDA consultants may also suggest precautions for women of childbearing age taking the drug, such as pregnancy tests and birth control.

Regulators have also raised the question of whether vaccinated people should receive the pill. Because the vaccine provides reliable protection against severe infection and death, the agency asked its consultants to assess whether vaccinated people would benefit enough from the drug to justify the risks.

Merck tablets were approved in the UK this month for people over 60 or with at least one risk factor for severe COVID-19.

Regulators in the European Union gave member states the go-ahead to approve emergency birth control pills last week as several countries in Europe grapple with a new wave of infections and introduce new closure measures.

The FDA is expected to soon review another antiviral pill – Paxlovid, developed by Pfizer – after the company asked for an emergency authorization last week. Pfizer, taken within three days of symptom onset, reduced mortality and hospitalization rates among high-risk patients by 89%, according to the company.

Nation World News Desk
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