Molnupiravir Archives - Amazing Health Advances

FDA: Merck COVID Pill Effective, Experts Will Review Safety

AHA Publisher — Wed, 01 Dec 2021 08:00:16 +0000

Matthew Perrone via CBN News – Federal health regulators say an experimental COVID-19 pill from Merck is effective against the virus, but they will seek input from outside experts on risks of birth defects and other potential problems during pregnancy. The Food and Drug Administration posted its analysis of the pill ahead of a public meeting next week where academic and other experts will weigh in on its safety and effectiveness. The agency isn’t required to follow the group’s advice. The FDA scientists said their review identified several potential risks, including possible toxicity to developing fetuses and birth defects that were identified in studies of the pill in animals. Given those risks, the FDA will ask its advisers next Tuesday whether the drug should never be given during pregnancy or whether it could be made available in certain cases. Under that scenario, the FDA said the drug would carry warnings about risks during pregnancy, but doctors would still have the option to prescribe it in certain cases where its benefits could outweigh its risks for patients. Given the safety concerns, FDA said Merck agreed the drug would not be used in children. Other side effects were mild and rare, with about 2% of patients experiencing diarrhea. Regulators also noted that Merck collected far less safety data overall on its drug than was gathered for other COVID-19 therapies. “While the clinical safety database was small, there were no major safety concerns identified,” FDA reviewers concluded. Additionally, the FDA flagged a concern that Merck’s drug led to small changes in the coronavirus’ signature spike protein, which it uses to penetrate human cells. Theoretically, FDA cautioned, those changes could lead to dangerous new variants. FDA will ask its independent advisers to discuss all those issues and then vote on whether the drug’s overall benefits outweigh its risks. All COVID-19 drugs currently authorized by the FDA require an injection or IV and can only be given by health professionals. If authorized, Merck’s drug would be the first that U.S. patients could take at home to ease symptoms and speed recovery. It is already authorized for emergency use in the U.K. The meeting marks the first time regulators have publicly reviewed a new drug for COVID-19, reflecting the intense interest and scrutiny of a pill that could be soon used by millions of Americans. The drug, molnupiravir, has been shown to significantly cut the rate of hospitalizations and deaths among people with mild-to-moderate coronavirus infections. Merck’s drug uses a novel approach to fight COVID-19: it inserts tiny mutations into the coronavirus’ genetic code to stop the virus from reproducing. But that genetic effect has raised concerns that in rare cases the drug could cause birth defects or even spur more virulent strains of the virus. Pregnant women were excluded from Merck’s study, and both women and men in the study were instructed to use contraception or abstain from sex. For its part, Merck says results from two company studies in rodents show the drug does not cause mutations or damage to DNA at the doses studied. FDA reviewers also confirmed previously reported interim results from Merck that the pill cut the rate of hospitalization and death by about half among patients with early symptoms of COVID-19 who faced increased risk due to health problems. However, on Friday morning Merck announced updated results from the same study that showed a smaller benefit from the drug. The FDA said it is still reviewing the updated data and would present a new assessment of the drug’s effectiveness next Tuesday. Among more than 1,400 adults in a company study, molnupiravir reduced the combined risk of hospitalization and death by 30%, less than the 50% initially reported based on incomplete results. Nearly 7% of patients who received Merck’s drug within five days of COVID-19 symptoms ended up in the hospital and one died. That compared to 10% of patients hospitalized who were taking the placebo and nine deaths. Merck didn’t study its drug in people who were vaccinated for COVID-19. But the FDA will ask advisers to recommend which patients may stand to benefit the most from the drug, based on vaccination status and underlying health problems. While Merck’s drug is likely to be the first pill for coronavirus in the U.S., more are expected to follow. Rival drugmaker Pfizer has submitted its own antiviral for FDA review after initial study results showed it cut the combined rate of hospitalization and death by nearly 90%. Pfizer’s drug is part of a decades-old family of antiviral pills known as protease inhibitors, which revolutionized the treatment of HIV and hepatitis C. They work differently than Merck’s pill and haven’t been linked to the kind of mutation concerns that have been raised with Merck’s drug. To read the original article click here.

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UK Gives OK to Merck’s Breakthrough Anti-COVID Pill, Pfizer Announces Its Antiviral Pill Works Too

AHA Publisher — Mon, 08 Nov 2021 08:00:32 +0000

CBN News – The United Kingdom granted conditional authorization Thursday to the first pill officially shown to successfully treat COVID-19. It’s the first country to OK the treatment from drugmaker Merck, but it is not known when the pill will be available to the public. Those with mild to moderate COVID symptoms would take four pills of molnupiravir, twice a day for five days. Adults 18 or older who have tested positive for COVID-19 and who could be at risk for developing severe disease, including people with issues like obesity or heart disease, are slated to be the first patients to receive the pill. Molnupiravir is also pending review with regulators in the U.S., the European Union, and other countries. Merck has said it can produce 10 million treatment courses through the end of the year, but much of that supply has already been purchased by governments worldwide, so initial supplies of the pill could be limited. “Today is a historic day for our country, as the U.K. is now the first country in the world to approve an antiviral that can be taken at home for COVID-19,” British Health Secretary Sajid Javid said. “We are working at pace across the government and with the NHS to set out plans to deploy molnupiravir to patients through a national study as soon as possible,” he said in a statement, referring to the U.K.’s National Health Service. Doctors said the treatment would be particularly significant for people who don’t respond well to vaccination. Merck announced preliminary results in September showing its drug cut hospitalizations and deaths by half among patients with early COVID-19 symptoms. The results haven’t yet been peer-reviewed or published in a scientific journal. Pfizer Announces Another Pill to Fight COVID On Friday, Pfizer also announced it has successfully tested an experimental antiviral pill for COVID-19 as well. Pfizer claims its pill cut rates of hospitalization and death by nearly 90%. Fewer than 1% of patients taking the drug needed to be hospitalized and no one died. “We were hoping that we had something extraordinary, but it’s rare that you see great drugs come through with almost 90% efficacy and 100% protection for death,” said Dr. Mikael Dolsten, Pfizer’s chief scientific officer. How Merck’s Drug Works The Merck drug targets an enzyme the coronavirus uses to reproduce itself, inserting errors into its genetic code that slow its ability to spread and take over human cells. That genetic activity has led some independent experts to question whether the drug could potentially cause mutations leading to birth defects or tumors. Britain’s Medicines and Healthcare products Regulatory Agency said molnupiravir’s ability to interact with DNA and cause mutations had been studied “extensively” and that it wasn’t found to pose a risk to humans. “Studies in rats showed that (molnupiravir) may cause harmful effects to the unborn offspring, although this was at doses which were higher than those that will be given to humans, and these effects were not observed in other animals,” the agency said in an email. Last week, Merck agreed to allow other drugmakers to make its COVID-19 pill, in a move aimed at helping millions of people in poorer countries receive the pill. The Medicines Patent Pool, a U.N.-backed group, said Merck will not receive royalties under the agreement for as long as the World Health Organization deems COVID-19 to be a global emergency. The U.S. has agreed to pay roughly $700 per course of the drug for about 1.7 million treatments. Merck says it plans to use a tiered pricing strategy for developing countries. A review by Harvard University and King’s College London estimated the drug costs about $18 to make each 40-pill course of treatment. Will Merck’s Pill Be Approved in the US? As CBN News reported last month, Merck requested U.S. Food and Drug Administration authorization for its COVID pill. The FDA said it would convene a panel of independent experts to scrutinize the pill’s safety and effectiveness later this month. “Of importance is that in the placebo group there were eight deaths, and in the treatment group there were no deaths,” said Dr. Anthony Fauci, director of the National Institutes of Allergy and Infectious Diseases. “That’s also very important and very good news.” Molnupiravir was initially studied as a potential flu therapy with funding from the U.S. government. Last year, researchers at Emory University decided to repurpose the drug as a potential COVID-19 treatment. They then licensed the drug to Ridgeback and partner Merck. To read the original article click here.

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New Antiviral Drug Completely Suppresses SARS-CoV-2 Transmission Within 24 Hours

AHA Publisher — Mon, 07 Dec 2020 08:00:05 +0000

Georgia State University via News-Medical Net – Treatment of SARS-CoV-2 infection with a new antiviral drug, MK-4482/EIDD-2801 or Molnupiravir, completely suppresses virus transmission within 24 hours, researchers in the Institute for Biomedical Sciences at Georgia State University have discovered. The group led by Dr. Richard Plemper, Distinguished University Professor at Georgia State, originally discovered that the drug is potent against influenza viruses. This is the first demonstration of an orally available drug to rapidly block SARS-CoV-2 transmission. MK-4482/EIDD-2801 could be game-changing.” Dr. Richard Plemper, Distinguished University Professor, Georgia State University Interrupting widespread community transmission of SARS-CoV-2 until mass vaccination is available is paramount to managing COVID-19 and mitigating the catastrophic consequences of the pandemic. Because the drug can be taken by mouth, treatment can be started early for a potentially three-fold benefit: inhibit patients’ progress to severe disease, shorten the infectious phase to ease the emotional and socioeconomic toll of prolonged patient isolation and rapidly silence local outbreaks. “We noted early on that MK-4482/EIDD-2801 has broad-spectrum activity against respiratory RNA viruses and that treating infected animals by mouth with the drug lowers the amount of shed viral particles by several orders of magnitude, dramatically reducing transmission,” said Plemper. “These properties made MK-4482/EIDD/2801 a powerful candidate for pharmacologic control of COVID-19.” In the study published in Nature Microbiology, Plemper’s team repurposed MK-4482/EIDD-2801 against SARS-CoV-2 and used a ferret model to test the effect of the drug on halting virus spread. “We believe ferrets are a relevant transmission model because they readily spread SARS-CoV-2, but mostly do not develop severe disease, which closely resembles SARS-CoV-2 spread in young adults,” said Dr. Robert Cox, a postdoctoral fellow in the Plemper group and a co-lead author of the study. The researchers infected ferrets with SARS-CoV-2 and initiated treatment with MK-4482/EIDD-2801 when the animals started to shed virus from the nose. “When we co-housed those infected and then treated source animals with untreated contact ferrets in the same cage, none of the contacts became infected,” said Josef Wolf, a doctoral student in the Plemper lab and co-lead author of the study. By comparison, all contacts of source ferrets that had received placebo became infected. If these ferret-based data translate to humans, COVID-19 patients treated with the drug could become non-infectious within 24 hours after the beginning of treatment. MK-4482/EIDD-2801 is in advanced phase II/III clinical trials against SARS-CoV-2 infection. To read the original article click here.

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