The pill, which is the first to be approved by the US Food and Drug Administration for treating chronic idiopathic constipation in adults, has been developed by Merck. It contains a drug called lubiprostone that helps patients move their bowels more easily.
Covid is a pill that was created to replace the vaccine. The pill is meant to be taken orally instead of injected.
In a pivotal study, Merck MRK 8.37 percent & Co. and its partner Ridgeback Biotherapeutics LP said their experimental Covid-19 pill helped prevent high-risk people from becoming seriously ill and dying early in the course of the disease, a major step toward developing the pandemic’s first easy-to-use, at-home treatment.
According to the firms, the tablet reduced the risk of hospitalization or death in trial participants with mild to moderate Covid-19 by nearly half.
The medication, known as molnupiravir, was doing so well in its late-stage study that Merck and Ridgeback claimed they had to stop recruiting people after talking to the US Food and Drug Administration.
The findings suggest that molnupiravir may be approved before the end of the year, providing a solution for physicians who have spent the epidemic looking for a medication that infected patients could take at home to avoid being hospitalized.
Merck intends to seek the FDA for permission to use the medication in the coming weeks, according to Chief Executive Rob Davis.
If approved by authorities, the medication would be Covid-19’s first oral antiviral. If participants followed the study’s protocol, they would take eight tablets daily for five days within five days of exhibiting symptoms.
Molnupiravir would act as a sort of Tamiflu for Covid-19, a drug that may be given to patients as soon as they show symptoms, reducing the virus’s progress in the body and possibly avoiding severe illness.
According to the newspaper, Covid-19 fatalities in the United States
Notes: Includes all 50 states plus D.C., as well as US territories and cruises. Source: Johns Hopkins Center for Systems Science and Engineering, last updated
“The capacity to take a terrible illness like Covid-19 and possibly make it manageable via what is a very simple round of delivery, which is an oral tablet you can take at home,” Mr. Davis said, has significant implications for the current epidemic.
If approved, the tablet would help convert Covid-19 from a fatal pandemic disease that overwhelms hospitals to a manageable sickness as it grows endemic in the community, working in tandem with vaccinations. “This will help us get to that endemic level and keep it there,” said Gabor Kelen, head of Johns Hopkins Medicine’s Department of Emergency Medicine.
Doctors are concerned, however, that the pill’s encouraging outcomes may inspire vaccination skeptics to feel more confident about not being vaccinated.
“First and foremost, vaccination is still the most effective and least dangerous thing you can do,” said John Mellors, head of the Division of Infectious Diseases at the University of Pittsburgh Medical Center and the University of Pittsburgh.
Merck and Ridgeback released the findings in a press statement after an early look at the study’s results, which are expected to be completed in November. The findings have yet to be published in a peer-reviewed publication.
The firms claimed that the incidence of adverse effects among trial participants who received molnupiravir and those who received a placebo was comparable, but they did not specify whether the medication was determined to be safe in the study. Mr. Davis, on the other hand, expressed his confidence in the drug’s safety profile.
According to the businesses, the medication seemed to be effective against circulating Covid-19 forms, including the highly infectious Delta.
Doctors are increasingly using monoclonal antibody medicines to treat Covid-19-infected high-risk individuals. The Wall Street Journal examines how the treatments work and why they’re crucial for saving lives. WSJ/Jacob Reynolds illustration
Following numerous failures, the findings position Merck, headquartered in Kenilworth, New Jersey, to play a bigger role in reacting to the pandemic. Merck agreed to assist Johnson & Johnson’s JNJ -0.64 percent shot after two of its experimental vaccines failed in testing. Merck also put a stop to the development of an investigational medicine it bought for $425 million.
According to Daina Graybosch, an analyst at Leerink LLC, Molnupiravir may produce $10 billion in sales cumulatively through 2025, given the possibility for stockpiling and its potential for preventing Covid-19, which is currently being researched. The announcement of the tablet boosted Merck’s stock by more than 9%.
Merck plans to manufacture 10 million treatment courses by the end of the year, with additional doses arriving the following year. Mr. Davis said Merck would start delivering dosages as soon as it was approved.
Should authorities approve the use of molnupiravir, the US has committed to pay Merck $1.2 billion for 1.7 million treatment sessions.
Merck said it intends to make the medication accessible worldwide and has entered into license arrangements with generic manufacturers to offer it to low-income nations, many of which have struggled to get vaccines to limit the virus’ spread.
Vaccines are the primary weapon in the battle against the pandemic, but physicians and health officials have been searching for medicines to prevent individuals who do get infected from developing serious disease and requiring hospitalization for a long time.
The medication choices are limited almost two years into the epidemic. Gilead Sciences Inc.’s Remdesivir, GILD -1.85 percent The only antiviral completely authorized by the FDA is GILD -1.54 percent, which is exclusively used to treat hospitalized patients.
For individuals with mild to severe Covid-19 who aren’t hospitalized, the FDA has approved antibody medicines manufactured by firms including Regeneron Pharmaceuticals Inc. REGN -5.68 percent and GlaxoSmithKline GSK -0.21 percent PLC and its partner Vir Biotechnology Inc. VIR -21.07 percent. In clinical studies, the medicines decreased the risk of hospitalization or death by at least 70%, a greater effectiveness rate than molnupiravir. However, administering antibody medicines is more difficult than taking a tablet, necessitating an intravenous infusion, which initially delayed their absorption.
For extremely ill individuals, dexamethasone, a steroid, is one of the most effective medicines against Covid-19.
“Even though the pill appears to have less benefit than monoclonal antibodies on the surface, it will have a much larger impact on the global stage because it will be so much easier to use,” said Daniel Kuritzkes, chief of the division of infectious diseases at Brigham and Women’s Hospital in Boston.
Dr. Mellors noted that although the company’ findings were promising, he still had concerns about how effective the medication is in vaccinated individuals who have breakthrough infections and how it compares to monoclonal antibodies. He said, “We need to see the whole data set.” He also stressed the need of long-term research on the drug’s safety.
Rajesh Gandhi, an infectious diseases physician at Massachusetts General Hospital and Harvard Medical School, wants to determine whether the tablet really reduced the length of symptoms and the severity of the illness in hospitalized patients.
He added that if the medication is approved and additional evidence becomes available, he would likely give it to outpatients with a risk factor, rather than those at low risk, and that antivirals are best begun early in the course of a disease, as Merck and Ridgeback investigated. He did say, however, that the medication would be beneficial to people who were at danger of serious disease.
“You could phone in a prescription for the patient, and they wouldn’t have to come in for an infusion or a subcutaneous injection, making it simpler, similar to how we treat influenza during flu season,” he said.
Molnupiravir was first created by Emory University’s not-for-profit biotechnology business. In early 2020, Ridgeback licensed and established a relationship with Emory, and subsequently announced a deal with Merck.
Molnupiravir works by targeting a different part of the virus than the spike protein on the coronavirus that Covid-19 vaccines and other Covid-19 medicines are designed to target. Molnupiravir attacks a component of the virus that aids in its reproduction.
“You will now have an oral, readily available, easily disseminated medication to keep patients out of the hospital and prevent them from dying,” Wayne Holman, co-founder of Ridgeback Pharmaceuticals in Miami, said.
Pfizer Inc., PFE -0.19 percent, Roche Holding AG, and Atea Pharmaceuticals Inc. are among the firms researching Covid-19 antivirals.
In April, Merck and Ridgeback halted a trial of molnupiravir in hospitalized patients after finding that it did not benefit them and was unlikely to decrease hospital stays and fatalities.
The firms proceeded to investigate whether the antiviral was effective early in the disease’s course and in individuals who are at high risk of Covid-19 problems. According to physicians and scientists, antivirals are most efficient when given immediately after infection and grow less effective as patients get worse.
More than 1,400 individuals were recruited in the Merck-Ridgeback late-stage, or Phase 3, trial, who were at high risk of getting severely sick with Covid-19. Participants have to be unvaccinated in order to participate. Half of the subjects were given an 800-milligram dosage of molnupiravir twice a day for five days, while the other half were given a placebo.
At least one feature linked with severe illness or mortality, such as old age, obesity, or diabetes, was classified as high risk. After the subjects experienced Covid-19 symptoms, treatment started five days later.
According to Merck and Ridgeback, 28 of the 385 individuals who got the medication were hospitalized after 29 days, compared to 53 of the 377 placebo subjects who were either hospitalized or died, resulting in an effectiveness rate of approximately 50%.
According to the businesses, no patients who took molnupiravir died throughout the 29-day study, compared to eight fatalities in the placebo group.
An outside group of independent specialists known as a data-safety monitoring committee conducted an interim assessment of the drug’s efficacy and safety, and then communicated its findings with Merck and Ridgeback.
Dr. Holman said the group convened late Tuesday to examine the data and then advised that the research be stopped because of the good findings. Following that, the businesses went to the FDA with their suggestion.
According to Mr. Davis, researchers will do a final analysis, which may result in the effectiveness % being modified, but the overall good conclusion should remain same.
In September, Merck and Ridgeback announced the start of a new experiment to see whether molnupiravir may prevent infection in individuals who have been exposed to the virus.
Jared S. Hopkins and Betsy McKay may be reached at [email protected] and [email protected], respectively.
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The Merck Pill Intended to Treat Covid is a drug that has been designed for the treatment of Covid. It is a pill and it acts as a contraceptive. Reference: is there a pill for covid-19.
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