Quantcast
More

    Trump will join Fox News’ Maria Bartiromo Sunday at 10am in his first interview since Election Day

    Donald Trump will join Fox News' Maria Bartiromo on Sunday at 10am in his first interview since Election Day as he continues to dispute...

    Raul Jimenez taken to hospital after being stretchered off just five minutes into Arsenal game

    Raul Jimenez taken to hospital after being forced off on a stretcher just five minutes into Wolves' trip to Arsenal after sickening clash of...

    Edinson Cavani facing FA probe after sparking racism storm

    Edinson Cavani facing FA probe after sparking racism storm for calling a friend 'negrito' in Instagram post just hours after inspiring Manchester United's comeback...

    FDA allows emergency use of antibody drug Trump received

    U.S. health officials Saturday agreed to allow emergency use of a second antibody drug to help the immune system fight COVID-19, an experimental medicine that President Trump was given when he was sickened last month.

    The Food and Drug Administration authorized use of the Regeneron Pharmaceuticals Inc. drug to try to prevent hospitalization and worsening disease from developing in patients with mild to moderate symptoms.

    The drug is given as a one-time treatment through an IV. The FDA allowed its use in adults and children 12 and over who weigh at least 88 pounds and who are at high risk of severe illness from COVID-19 because of age or certain other medical conditions.

    Mexico last week passed two somber coronavirus markers, exceeding 100,000 deaths and 1 million infections. The grim statistics brought renewed political wrangling about how the country’s leadership has handled the pandemic.

    Emergency authorization allows use of the drug to start while studies are continuing to establish safety and effectiveness. Early results suggest the drug may reduce COVID-19-related hospitalization or emergency room visits in patients at high risk for disease progression, the FDA said.

    Regeneron said that initial doses will be made available to roughly 300,000 patients through a federal government allocation program. Patients will not be charged for the drug but may have to pay part of the cost of giving the IV.

    Initial supplies will likely be vastly outstripped by demand as the U.S. has surged past 10 million reported cases, with the country facing what health experts say will be a dark winter due to uncontrolled spread of the virus.

    Antibodies are proteins the body makes to target and help eliminate viruses, but it can take weeks for the best ones to form after an infection occurs. The drugs are concentrated versions of ones that proved best able to do this in lab and animal tests, and in theory help the body start to fight the virus right away.

    The Regeneron drug is a combo of two antibodies to enhance the chances it will prove effective. Earlier this month, the FDA gave emergency authorization to a single-antibody drug from Eli Lilly that also is still being studied.

    There’s no way to know whether the Regeneron drug helped Trump recover; he received a host of treatments, and most COVID-19 patients recover on their own.

    FDA regulators authorized the Regeneron drug using their emergency powers to quickly speed the availability of experimental drugs and other medical products during public health crises.

    In normal times the FDA requires “substantial evidence” to show that a drug is safe and effective, usually through one or more large, rigorously controlled patient studies. But during public health emergencies the agency can lower those standards and require only that an experimental treatment’s potential benefits outweigh its risks.

    The emergency authorization functions like a temporary approval for the duration of the COVID-19 pandemic. To win full approval, Regeneron will have to submit additional research to fully define the drug’s safety and benefit for patients.

    LEAVE A REPLY

    Please enter your comment!
    Please enter your name here

    Latest Posts

    How good news on the Australian economy will boost the share market

    How Australians with shares in supermarkets and banks are set to cash in this week as profits bounce back National accounts data for September quarter...

    Australian pop star Gabriella Cilmi hasn’t aged a day since teenage stardom

    Australian pop star Gabriella Cilmi, now 29, hasn't aged a day since rising to fame as a teenager - and is now living a...

    Whitney Port is Sunday casual in sweatshirt and baggy sweats as she runs errands in LA

    Whitney Port is Sunday casual in sweatshirt and baggy sweats as she runs errands in LA By Rachel Mcgrath For Dailymail.com Published: 01:18...

    Covid-19 cases fall by a THIRD, new study finds

    Covid-19 cases fall by a THIRD: Infections have plummeted since second national lockdown as new figures reveal 30% drop across the country... and numbers...