Purpose-made drug is approved in UK
The drug which was given to Donald Trump to prevent and fight Covid-19 has been approved for use in the UK
The UK’s medicines regulator has approved the use of the drug previously known as REGN-Cov2.
Health Secretary Sajid Javid said approval of the first treatment designed specifically for Covid-19 in the UK is “fantastic news” and he hopes it can be rolled out for patients on the NHS “as soon as possible”.
The Medicines and Healthcare products Regulatory Agency (MHRA) said the clinical trial data it assessed showed that Ronapreve can be used to prevent infection, treat symptoms of serious infection and cut the likelihood of being admitted to hospital.
Trials took place before widespread vaccination and before the emergence of virus variants.
It is the first monoclonal antibody combination product approved for use in the prevention and treatment of acute infection from the virus in the UK.
Monoclonal antibodies are man-made proteins that act like natural human antibodies in the immune system.
The drug, developed by pharmaceutical firms Regeneron and Roche, is given either by injection or infusion and acts at the lining of the respiratory system where it binds tightly to the virus and prevents it from gaining access to the cells, the MHRA said.
Mr Javid said: “The UK is considered a world leader in identifying and rolling out life-saving treatments for Covid-19, once they have been proven safe and effective in our government-backed clinical trials.
“This is fantastic news from the independent medicines regulator and means the UK has approved its first therapeutic designed specifically for Covid-19.
“This treatment will be a significant addition to our armoury to tackle Covid-19 – in addition to our world-renowned vaccination programme and life-saving therapeutics dexamethasone and tocilizumab.
“We are now working at pace with the NHS and expert clinicians to ensure this treatment can be rolled out to NHS patients as soon as possible.”
MHRA interim chief quality and access officer Dr Samantha Atkinson said: “We are pleased to announce the approval of another therapeutic treatment that can be used to help save lives and protect against Covid-19.
“Ronapreve is the first of its kind for the treatment of Covid-19 and, after a meticulous assessment of the data by our expert scientists and clinicians, we are satisfied that this treatment is safe and effective.
“With no compromises on quality, safety and efficacy, the public can trust that the MHRA have conducted a robust and thorough assessment of all the available data.”
The Department of Health said it will set out further details of how the treatment will be deployed to patients “in due course”.
Professor Martin Landray, professor of medicine and epidemiology at the Nuffield Department of Population Health, University of Oxford, said the approval is “an important step forward” and that it could play “an important role” in helping patients at higher risk from the virus, noting that it had been administered to Mr Trump last year.
He said: “The challenge going forward will be in determining which patients should be prioritised for this treatment. Covid is not a rare disease and many people get better of their own accord after a few days of a nasty flu-like illness.
“It would be hard to justify giving what are likely to be limited supplies of a relatively expensive treatment to huge numbers of people who are likely to get better on their own.
“On the other hand, it may play an important role in patients who are at higher risk of developing severe infection and who are more likely to end up in hospital.”
Professor Penny Ward, independent pharmaceutical physician and visiting professor in pharmaceutical medicine at Kings College, London, said it is a “good news day” and suggested how the drug might be deployed.
“I think it is most likely to be used to prevent hospitalisation among people becoming sick with Covid who are at higher risk of needing hospital care/dying from disease,” she said.
She added that it might also be used to prevent Covid infections in people who are in contact with a confirmed case and who might have reduced response to vaccination, such as those being treated for cancer or who have had a transplant.
She suggested it could also be used to “curtail outbreaks” in places like care homes, hospitals, prisons and critical workplaces.
New COVID Antivirals Are Coming
People newly infected with COVID-19 might soon have access to what essentially is Tamiflu for the novel coronavirus, a breakthrough that experts say would drastically alter the course of the ongoing pandemic
At least three contenders are vying to become the first antiviral pill that specifically targets COVID-19, according to reports from drug manufacturers.
Such a pill could be prescribed by your doctor and taken while you recuperate at home, potentially limiting the impact of a COVID infection on your body.
Merck & Co.'s antiviral drug molnupiravir leapt into the lead on Friday. That's when the company announced it will ask for quick U.S. approval for emergency use of their pill, after clinical trials showed it halved patients' risk of hospitalization or death from COVID.
But two other candidates also are well along in clinical trials: one from Pfizer Inc. and another from Roche and Atea Pharmaceuticals.
If they prove safe and effective, these drug candidates could keep people infected with COVID out of the hospital and prevent those around them from contracting the coronavirus, experts said.
"These are all drugs that in one way or another interfere with the multiplication of the virus," said Dr. William Schaffner, medical director of the Bethesda, Md.-based National Foundation for Infectious Diseases.
"If you were exposed and the virus is already in your body starting to multiply, if we could get in there early with these drugs that inhibit their multiplication, obviously the virus can't spread to other parts of your body -- thus sparing you developing illness or getting a milder illness," Schaffner said. "It also would make you less contagious to others."
People living with a COVID patient also might be able to get a prescription for one of these antivirals, Schaffner said.
"It might well be that we could give these drugs to family members who are exposed and never have them develop any infection at all," Schaffner said.
Existing treatments are flawed
There are already antiviral treatments available for people in the early throes of COVID, but they each have flaws that limit their usefulness.
Doctors have been using remdesivir -- a drug developed to treat Ebola -- to curb the damage done by a COVID infection, but its effectiveness is limited, said Dr. Amesh Adalja, a senior scholar with the Johns Hopkins Center for Health Security.
"What we've seen so far, drugs like remdesivir are not really knockout punches because they are kind of repurposed" from the viruses they originally targeted, Adalja said.
Monoclonal antibodies also can attack the virus in early infection, but "as you know they're in short supply and they're pretty darned expensive," Schaffner said. "They have to be given either intravenously or through a series of multiple injections under the skin, all of which makes things even more expensive, and you have to go to designated locations for treatment."
Adalja said, "What we've always needed is a Tamiflu equivalent to keep people out of the hospital, to decrease complications, but it takes time for antiviral drugs to be made because they're so specific to the viruses that are causing disease." Prescribed for flu, Tamiflu (oseltamivir) reduces flu symptoms and shortens recovery time.
Merck's announcement was electrifying, in part because the clinical trial results from molnupiravir were so positive that an independent data monitoring committee recommended stopping the study early so the company could pursue an emergency use authorization from the U.S. Food and Drug Administration.
Early results from phase 3 trials showed that molnupiravir cut the risk of hospitalization or death from COVID-19 by about 50%.
Around 7% of COVID patients treated with molnupiravir were either hospitalized or died within a month of taking the drug, compared with 14% of patients who received a placebo. The analysis was based on data from 775 patients who'd enrolled early in the trial.
Keeping people at home is a priority
"We always believed antivirals, especially an oral antiviral, would be an important contribution to the pandemic," Daria Hazuda, vice president of infectious diseases and vaccine discovery at Merck, told the Washington Post. "Keeping people out of the hospital is incredibly important, given the emergence of variants and the continued evolution of the virus."
Merck's news comes on the heels of Pfizer's announcement early last week that it had entered phase 2/3 clinical trials for a COVID antiviral it calls PF-07321332.
Pfizer's drug candidate would be taken in combination with the antiretroviral HIV drug ritonavir to see if it could keep COVID from spreading to healthy trial participants living in the same household as someone with a confirmed infection, the company said in a statement.
The trial plans to enroll up to 2,660 people who will be randomly assigned to receive either the pill or a placebo twice daily for 5 to 10 days.
Meanwhile, Roche and Atea Pharmaceuticals announced positive early results for its own experimental antiviral, AT-527, in late June.
Early data from phase 2 trials showed that in two days the pill reduced the viral load of COVID patients by 80% on average compared to placebo. However, the early analysis only involved data from 62 hospitalized, high-risk patients.
The Roche-Atea pill wound up clearing about 47% of patients within two weeks, making them completely COVID-free. By comparison, 22% of people taking a placebo were cleared of COVID in the same time frame.
Roche and Atea expect to announce more results from phase 2 and 3 trials later this year, the companies said.
The prospect of curbing COVID at home with a pill is cause for cautious celebration, Schaffner said.
"Isn't it great that we have at least three different firms working on three different drugs?" Schaffner said. "It's like the Olympics. We want to see who gets there first, but we would like to see all three of them be successful."
Return to Kurdistan Today News (Only News)
Registered users: No registered users