Posts tagged with "Emergency use authorization"

GlaxoSmithKline requests emergency authorization from FDA for COVID monoclonal antibody drug

March 29, 2021

On Friday, March 26, GlaxoSmithKline and Vir Biotechnology  applied for an emergency use authorization from the Food and Drug Administration for their monoclonal antibody drug, CNBC reports.

The companies are requesting clearance for use by high-risk patients, age 12 and older.

The FDA submission is based on an interim analysis of a phase three trial that evaluated the drug for the early treatment of COVID-19 in adults at high risk of hospitalization. The drug reduced hospitalizations or death from COVID by 85% compared with a placebo. The trial results were based on 583 patients.

“As a result, the Independent Data Monitoring Committee recommended that the trial be stopped for enrolment due to evidence of profound efficacy,” the companies said in a statement.

The companies started testing the antibody on early-stage COVID patients in August, CNBC notes—hoping to keep symptoms from progressing. Antibody drugs gained attention after they were used to treat former President Donald Trump last year.

U.S. health officials say antibody drugs already authorized for use—from Regeneron and Eli Lilly—are being underutilized.

GSK said the companies will also continue discussions with the European Medicines Agency and other global regulators to make the drug available to COVID patients as soon as possible.

Research contact: @CNBC

J&J vaccine provides strong shield against acute COVID-19, prevents hospitalizations

February 1, 2021

Johnson & Johnson’s one-shot vaccine has generated strong protection against acute COVID-19 in a large, late-stage trial—raising hopes that it can rapidly reshape a stumbling immunization campaign, Bloomberg reports.

In a study of more than 43,000 people, the vaccine prevented 66% of moderate to severe cases of COVID-19, according to a company statement released on Friday, January 29.

And it was particularly effective at stopping severe disease—preventing 85% of severe infections and 100% of hospitalizations and deaths.

“If you can prevent severe disease in a high percentage of individuals, that will alleviate so much of the stress and human suffering” of the pandemic, said Anthony Faucidirector of the National Institute of Allelrgy and Infectious Diseases (NIAID) and the top U.S. infectious-disease official—at a briefing on the results with company and government officials.

Based on the result, J&J plans to file with the U.S. Food and Drug Administration for an emergency-use authorization next week. The drug giant’s top scientist said this month he expects a clearance in March, and that it would have product ready to ship then.

The company didn’t specify how much of the vaccine would be available immediately, although it reaffirmed that the United States will receive 100 million doses by the end of June, Bloomberg said.

J&J’s vaccine is different from the messenger RNA-based shots made by Moderna and partners Pfizer and BioNTech SE. It is based on an adenovirus, or cold germ that has been modified to make copies of the coronavirus spike protein—which the pathogen uses to force its way into cells. The altered virus can’t replicate in humans, but it triggers an immune response that prepares the body to defend itself against the coronavirus. J&J uses the same technology in a vaccine to fight Ebola.

J&J’s R&D head said the company’s trial, conducted at the height of the pandemic, had to deal with resistant variants that arose mainly after Moderna’s and Pfizer’s trials were finished. When counting cases, it also focused on somewhat sicker patients, Mammen said.

“If those vaccine programs accrued cases at the same time as us, when viral infections were so much higher, incidents were higher, and variants were all around us, they would have gotten different numbers,” he said. “The fact that we could do this level of efficacy with a single shot—people don’t have to come back for another, and it’s conveniently stored— well that makes this the vaccine of choice.”

At the outset of the pandemic, U.S. government officials said any vaccine showing greater than 50% efficacy would be considered a success.

Research contact: @Bloomberg

The buddy system: Provider of Trump COVID drug is president’s golf pal

October 11, 2020

New questions have emerged over the circumstances under which Donald Trump was prescribed an experimental antibody drug cocktail to treat his coronavirus infection now that the public knows that the source of the pharmaceuticals was the president’s golfing buddy.

As Trump wrongly hailed his treatment–which included a drug called REGN-COV2 produced by Tarrytown, New York-based Regeneron—as a “cure”, it emerged that the company’s CEO Leonard Schleifer  is a member of the Trump National Golf Club in Westchester County, New York, and had met the president in May to talk about drugs his company was developing The Guardian reports.

REGN-COV2 is a combination of two monoclonal antibodies designed to both treat people with coronavirus and to prevent Sars-CoV-2 infection. The antibodies are designed to prevent the coronavirus spike protein from attaching to Ace2 receptors in the body–the path the virus uses to infect people.

While some ethicists have defended Trump’s privileged access as president to experimental treatments, others have suggested it raises questions of fairness among other concerns, including his history of touting unproven treatments.

Trump’s relationship with Schleifer, whom he reportedly calls “Lenny,” adds to growing questions over the president’s almost exclusive access to experimental treatments unavailable to most other Americans, even as he has continued to downplay the threat of coronavirus based on his own experience.

The price of Regeneron stocks–which Trump has owned in the past–soared after it was revealed the drug had been made available for his treatment and Trump stated it would be made freely available for all, although he didn’t explain how.

“I call that a cure,” Trump said in a video, adding that everyone should have access to the not-yet-approved drug and that he would make sure it was in every hospital as soon as possible.

Trump’s comments were quickly criticized by doctors treating patients on the frontline of the COVID-19 pandemic in the United States.

Frankly, he is an anecdote, and he is an anecdote meaning he is one person who took this drug, but he has also taken dexamethasone,” said ER professional Dr Rob Davidson, who works in west Michigan, on Twitter.

Davidson added in his interview with the Guardian that Dexamethasone (a corticosteroid that prevents the release of substances in the body that cause inflammation) “makes you feel like a million bucks, it makes you feel like you’re on top of the world”.

He concluded: “Do everything the opposite of what this administration is telling you.”

After the president’s comments, Regeneron announced it had applied to the Food and Drug Administration (FDA) for an emergency use authorization.

“There are doses available for approximately 50,000 patients, and we expect to have doses available for 300,000 patients in total within the next few months,” the company said in a statement.

However, America is seeing more than 50,000 new cases of Covid-19 each day. Further, monoclonal antibody therapies are notoriously difficult to produce and expensive. The median cost of monoclonal antibody therapies approved over the last 20 years is more than $96,000 per treatment course.

Regeneron’s therapy has only been tested in 275 people, in a promising study that some scientists nevertheless said, “doesn’t cut it” for emergency use authorization.

The drug has also stirred debate because of how it was developed, The Guardian notes–using an “immortalized” cell line originally derived from an elective abortion in the Netherlands in the 1970s—a common process that the Trump administration opposes.

Republicans opposes embryonic stem cell research, according to the party platform.

The White House doctor, Sean Conley, said Trump had been given a single 8g dose that was made available under a compassionate use clause. Compassionate use requests are decided on a case-by-case basis—and both the drug company and the FDA must agree.

The Regeneron spokeswoman Alexandra Bowie said fewer than 10 of these requests had been granted, and with the drug in limited supply the priority was to use it in ongoing studies. Emergency access was granted “only in rare and exceptional circumstances”, she said.

Regeneron also contacted the Democratic presidential candidate, Joe Biden, to alert him to the availability of the drug under the compassionate use rule.

Alison Bateman-House, an ethicist at New York University Langone Health, told The Guardian that Regeneron’s overture to Biden should raise concerns.

“That crosses lines of appearing to promote a potentially unapproved product,” she told Associated Press, which would violate FDA rules. Rather than directing people to enrol in studies, she said it suggested that “we’ll cut the line for you”.

New questions have emerged over the circumstances under which Donald Trump was prescribed n experimental antibody drug cocktail to treat his coronavirus infection now that the public knows that the source of the pharmaceuticals was the president’s golfing buddy.

As Trump wrongly hailed his treatment–which included a drug called REGN-COV2 produced by Tarrytown, New York-based Regeneron—as a “cure”, it emerged that the company’s CEO Leonard Schleifer  is a member of the Trump National Golf Club in Westchester County, New York, and had met the president in May to talk about drugs his company was developing The Guardian reports.

REGN-COV2 is a combination of two monoclonal antibodies designed to both treat people with coronavirus and to prevent Sars-CoV-2 infection. The antibodies are designed to prevent the coronavirus spike protein from attaching to Ace2 receptors in the body–the path the virus uses to infect people.

While some ethicists have defended Trump’s privileged access as president to experimental treatments, others have suggested it raises questions of fairness among other concerns, including his history of touting unproven treatments.

Trump’s relationship with Schleifer, whom he reportedly calls “Lenny,” adds to growing questions over the president’s almost exclusive access to experimental treatments unavailable to most other Americans, even as he has continued to downplay the threat of coronavirus based on his own experience.

The price of Regeneron stocks–which Trump has owned in the past–soared after it was revealed the drug had been made available for his treatment and Trump stated it would be made freely available for all, although he didn’t explain how.

“I call that a cure,” Trump said in a video, adding that everyone should have access to the not-yet-approved drug and that he would make sure it was in every hospital as soon as possible.

Trump’s comments were quickly criticized by doctors treating patients on the frontline of the COVID-19 pandemic in the United States.

Frankly, he is an anecdote, and he is an anecdote meaning he is one person who took this drug, but he has also taken dexamethasone,” said ER professional Dr Rob Davidson, who works in west Michigan, on Twitter.

Davidson added in his interview with the Guardian that Dexamethasone (a corticosteroid that prevents the release of substances in the body that cause inflammation) “makes you feel like a million bucks, it makes you feel like you’re on top of the world”.

He concluded: “Do everything the opposite of what this administration is telling you.”

After the president’s comments, Regeneron announced it had applied to the Food and Drug Administration (FDA) for an emergency use authorization.

“There are doses available for approximately 50,000 patients, and we expect to have doses available for 300,000 patients in total within the next few months,” the company said in a statement.

However, Americais seeing more than 50,000 new cases of Covid-19 EaCH day. Further, monoclonal antibody therapies are notoriously difficult to produce and expensive. The median cost of monoclonal antibody therapies approved over the last 20 years is more than $96,000 per treatment course.

Regeneron’s therapy has only been tested in 275 people, in a promising study that some scientists nevertheless said, “doesn’t cut it” for emergency use authorization.

The drug has also stirred debate because of how it was developed, The Guardian notes–using an “immortalized” cell line originally derived from an elective abortion in the Netherlands in the 1970s—a common process that the Trump administration opposes.

Republicans opposes embryonic stem cell research, according to the party platform.

The White House doctor, Sean Conley, said Trump had been given a single 8g dose that was made available under a compassionate use clause. Compassionate use requests are decided on a case-by-case basis—and both the drug company and the FDA must agree.

The Regeneron spokeswoman Alexandra Bowie said fewer than 10 of these requests had been granted, and with the drug in limited supply the priority was to use it in ongoing studies. Emergency access was granted “only in rare and exceptional circumstances”, she said.

Regeneron also contacted the Democratic presidential candidate, Joe Biden, to alert him to the availability of the drug under the compassionate use rule.

Alison Bateman-House, an ethicist at New York University Langone Health, told The Guardian that Regeneron’s overture to Biden should raise concerns.

“That crosses lines of appearing to promote a potentially unapproved product,” she told Associated Press, which would violate FDA rules. Rather than directing people to enrol in studies, she said it suggested that “we’ll cut the line for you”.

Research contact: @GuardianUS