Connect with us


UK approved COVID-19 antivirals are still being reviewed by Health Canada-National




Health Canada says it is still reviewing data on antiviral drugs COVID-19 (New Coronavirus Infection) A drug approved Thursday in the United Kingdom.

Federal regulators say they continue to receive data on the drug molnupiravir “as new information becomes available” from the drug company Merck, which is considered the first tablet to successfully treat COVID-19. I did.

No timeline is provided to complete the review process.

“We can’t predict when regulatory decisions will be made because the review is still underway,” Health Canada said in an email.

read more:

UK approves Merck’s antiviral drug to treat COVID-19

Molnupiravir was given conditional approval for use in the United Kingdom, but it was not immediately clear how quickly pills would be available in the United Kingdom.

The story continues under the ad

Merck has provided rolling data to Health Canada since August, when the product was still in clinical trials.

Health Canada said in an email earlier Thursday that it was “waiting for the final package of manufacturing data” from Merck, but later that day said a statement was erroneously issued, but soon. I didn’t explain in detail.

Regulators said the review would determine if the benefits of using the drug outweigh the risks and ensure that they meet “strict safety, efficacy and quality requirements.”

Click to play video:

Infectious disease doctors respond after Merck’s antivirals approved for use in the United Kingdom

Infectious disease doctors respond after Merck’s antivirals approved for use in the United Kingdom

Merck released preliminary results in September, halving hospitalizations and deaths for patients with early COVID-19 symptoms. The results have not yet been peer-reviewed and have not been published in scientific journals.

The company also did not provide details on the side effects of molnupiravir, but said the incidence of these problems was similar between those who took the drug and those who took dummy tablets.

The story continues under the ad

Molnupiravir was initially funded by the US government and studied as a potential treatment for influenza. Last year, researchers at Emory University decided to reuse the drug as a potential treatment for COVID-19. They then licensed the drug to Ridgeback and his partner Merck.

The drug targets the enzyme that the coronavirus uses to replicate itself, inserting errors into the genetic code and delaying the ability of human cells to spread and take over. Its genetic activity has led some independent experts to question whether the drug can cause mutations that lead to birth defects and tumors.

read more:

Experimental pills fight COVID-19, pharmaceutical company Merck claims

The UK Medicines and Healthcare Products Regulatory Agency said the ability of molnupiravir to interact with DNA to cause mutations has been “extensively” studied and has not been found to pose a risk to humans.

Dr. Sumon Chakrabarti, an infectious disease expert in Mississauga, Ontario, said it was intriguing because the error that Molnupiravir inserted into the genetic code was not recognized as an error by the SARS-CoV-2 virus.

“Therefore, a large mutation occurs and the virus dies,” he said. “In fact, it’s a little cool.”

Merck Canada announced Thursday that Health Canada will decide to approve after reviewing “all the evidence needed.”

The company added that the supply contract has not yet been signed, but talks with the Canadian government are ongoing.

The story continues under the ad

Click to play video:'Fauci describes Merck's data on COVID-19 pill treatment as

Fauci says Merck’s data on COVID-19 pill treatment is “impressive”

Fauci states that Merck’s data on COVID-19 pill treatment is “impressive” – October 1, 2021

In an email from the Media Center, Merck continues to work with the government to give Canadians access to our medicines when marketed by Health Canada. “.

Chakrabarti said the current situation of the COVID-19 epidemic in the UK, where “massive hospitalizations are slowly burning”, provided more urgency to regulators there to conditionally approve the drug. I said it might be.

He said Health Canada would consider using the drug “in the Canadian context.”

“They were pretty good about not rushing things,” he said of Canadian regulators. “They look at the data and when they make a recommendation, you can trust it.”

read more:

Regeneron’s antibody COVID-19 treatment is popular in the United States — why not in Canada?

The story continues under the ad

Molnupiravir is also pending reviews with the United States, the European Union and other regulatory agencies. The US Food and Drug Administration announced last month that it would convene a panel of independent experts to scrutinize the safety and efficacy of pills in late November.

Merck and its partner Ridgeback Biotherapeutic have requested approval for the drug in adults with early cases of COVID-19 who are at risk of severe illness or hospitalization.

Take-away pills have been approved in the UK for adults over the age of 18 who test positive for COVID-19 and have at least one risk factor for developing serious illnesses such as obesity and heart disease. .. Patients with mild to moderate COVID-19 take 4 tablets twice daily for 5 days.

Chakrabalti, who has never seen data from clinical trials, said the caveat to the drug is that it should be taken early, either immediately after exposure or during the first few days of infection.

“The absolute risk reduction doesn’t seem to be that high, but at least it’s another tool in the box,” he said. “Anything we can use to prevent hospitalization is fine.”

— Use files from Associated Press

© 2021 The Canadian Press





The mention sources can contact us to remove/changing this article

What Are The Main Benefits Of Comparing Car Insurance Quotes Online

LOS ANGELES, CA / ACCESSWIRE / June 24, 2020, / Compare-autoinsurance.Org has launched a new blog post that presents the main benefits of comparing multiple car insurance quotes. For more info and free online quotes, please visit https://compare-autoinsurance.Org/the-advantages-of-comparing-prices-with-car-insurance-quotes-online/ The modern society has numerous technological advantages. One important advantage is the speed at which information is sent and received. With the help of the internet, the shopping habits of many persons have drastically changed. The car insurance industry hasn't remained untouched by these changes. On the internet, drivers can compare insurance prices and find out which sellers have the best offers. View photos The advantages of comparing online car insurance quotes are the following: Online quotes can be obtained from anywhere and at any time. Unlike physical insurance agencies, websites don't have a specific schedule and they are available at any time. Drivers that have busy working schedules, can compare quotes from anywhere and at any time, even at midnight. Multiple choices. Almost all insurance providers, no matter if they are well-known brands or just local insurers, have an online presence. Online quotes will allow policyholders the chance to discover multiple insurance companies and check their prices. Drivers are no longer required to get quotes from just a few known insurance companies. Also, local and regional insurers can provide lower insurance rates for the same services. Accurate insurance estimates. Online quotes can only be accurate if the customers provide accurate and real info about their car models and driving history. Lying about past driving incidents can make the price estimates to be lower, but when dealing with an insurance company lying to them is useless. Usually, insurance companies will do research about a potential customer before granting him coverage. Online quotes can be sorted easily. Although drivers are recommended to not choose a policy just based on its price, drivers can easily sort quotes by insurance price. Using brokerage websites will allow drivers to get quotes from multiple insurers, thus making the comparison faster and easier. For additional info, money-saving tips, and free car insurance quotes, visit https://compare-autoinsurance.Org/ Compare-autoinsurance.Org is an online provider of life, home, health, and auto insurance quotes. This website is unique because it does not simply stick to one kind of insurance provider, but brings the clients the best deals from many different online insurance carriers. In this way, clients have access to offers from multiple carriers all in one place: this website. On this site, customers have access to quotes for insurance plans from various agencies, such as local or nationwide agencies, brand names insurance companies, etc. "Online quotes can easily help drivers obtain better car insurance deals. All they have to do is to complete an online form with accurate and real info, then compare prices", said Russell Rabichev, Marketing Director of Internet Marketing Company. CONTACT: Company Name: Internet Marketing CompanyPerson for contact Name: Gurgu CPhone Number: (818) 359-3898Email: [email protected]: https://compare-autoinsurance.Org/ SOURCE: Compare-autoinsurance.Org View source version on accesswire.Com:https://www.Accesswire.Com/595055/What-Are-The-Main-Benefits-Of-Comparing-Car-Insurance-Quotes-Online View photos


to request, modification Contact us at Here or [email protected]