FDA approves first COVID-19 drug: antiviral remdesivir

[steven36]

U.S. regulators on Thursday approved the first drug to treat COVID-19: remdesivir, an antiviral medicine given to hospitalized patients through an IV.

 

 

The drug, which California-based Gilead Sciences Inc. is calling Veklury, cut the time to recovery by five days — from 15 days to 10 on average — in a large study led by the U.S. National Institutes of Health.

 

It had been authorized for use on an emergency basis since spring, and now becomes the first drug to win full Food and Drug Administration approval for treating COVID-19. President Donald Trump received it when he was sickened earlier this month.

 

Veklury is approved for people at least 12 years old and weighing at least 88 pounds (40 kilograms) who are hospitalized for a coronavirus infection. For patients younger than 12, the FDA will still allow the drug’s use in certain cases under its previous emergency authorization.

 

The drug works by inhibiting a substance the virus uses to make copies of itself. Certain kidney and liver tests are required before starting patients on it to ensure it’s safe for them and to monitor for any possible side effects. And the label warns against using it with the malaria drug hydroxychloroquine, because that can curb its effectiveness.

 

“We now have enough knowledge and a growing set of tools to help fight COVID-19,” Gilead’s chief medical officer, Dr. Merdad Parsey, said in a statement.

 

The drug is either approved or has temporary authorization in about 50 countries, he noted.

 

Its price has been controversial, given that no studies have found it improves survival. Last week, a large study led by the World Health Organization found the drug did not help hospitalized COVID-19 patients, but that study did not include a placebo group and was less rigorous than previous ones that found a benefit. The FDA’s approval statement noted that, besides the NIH-led one, two other studies found the drug beneficial.

 

Gilead charges $2,340 for a typical treatment course for people covered by government health programs in the United States and other developed countries, and $3,120 for patients with private insurance. The amount that patients pay out of pocket depends on insurance, income and other factors.

 

So far, only steroids such as dexamethasone have been shown to cut the risk of dying of COVID-19. The FDA also has given emergency authorization to using the blood of survivors, and two companies are currently seeking similar authorization for experimental antibody drugs.

Source

[Karlston]

Huge COVID study finds remdesivir doesn’t work—FDA grants approval anyway

WHO says its massive study was clearly not included in FDA review.

Enlarge / A vial of Remdesivir during a press conference about the start of a study with severely COVID-19 patients in Hamburg, Germany on April 8, 2020.

Getty | Ulrich Perrey

54 with 41 posters participating

The US Food and Drug Administration on Thursday issued a full approval of the antiviral drug remdesivir for treating COVID-19—just days after a massive global study concluded that the drug provides no benefit.

 

“The FDA is committed to expediting the development and availability of COVID-19 treatments during this unprecedented public health emergency,” FDA Commissioner Stephen Hahn said in a statement. “Today’s approval is supported by data from multiple clinical trials that the agency has rigorously assessed and represents an important scientific milestone in the COVID-19 pandemic.”

Early results

The FDA made its decision based on three clinical trials on remdesivir, a repurposed experimental antiviral drug brand-named Veklury. One was a randomized, double-blind, placebo-controlled trial run by the National Institute of Allergy and Infectious Diseases. It included 1,062 hospitalized COVID-19 patients, 541 of which received remdesivir. The trial concluded that remdesivir shortened the median recovery time from the infection from 15 days to 10 days. The researchers running the trial defined “recovery” of a patient as either a patient being discharged from the hospital—regardless if the patient still had lingering symptoms that limited activities or required supplemental oxygen to be taken at home—or a patient remaining in the hospital but no longer requiring medical care, such as if they were kept in the hospital for infection-control reasons.

 

The other two trials the FDA considered were conducted by Gilead, the company that makes remdesivir. One trial looked at about 600 people with moderate cases COVID-19. Patients were split into three groups, each about 200 people—a group that got a 10-day course of remdesivir, a group that got a 5-day course, and a control group that got standard treatments. At day 11 of treatments, the group that had the 5-day course of remdesivir showed a statistically significant improvement in symptom scores compared with the control group. The group that got a 10-day course of remdesivir did not have a statistically significant improvement over the control group, though.

 

The other Gilead trial looked at 400 patients with severe COVID-19. They were split about evenly into just two groups—a group that got a 5-day course of remdesivir and a group that got a 10-day course. There were no statistically significant differences in recovery or deaths between the two groups.

Missing data

“The [FDA] approval of Veklury marks an important milestone in efforts to help address the pandemic by offering an effective treatment that helps patients recover faster and, in turn, helps preserve scarce healthcare resources,” Barry Zingman said in a press statement released by Gilead. Zingman is a professor at Albert Einstein College of Medicine and one of the researchers who conducted the NIAID trial of remdesivir.

 

But the FDA’s approval of remdesivir falls on the heels of data form the fourth and largest trial of the drug, and that trial showed no benefit. The data comes from the World Health Organization’s massive Solidarity trial, which set up an international network of trials enrolling nearly 12,000 patients at 500 sites in over 30 countries, testing multiple repurposed therapeutics. Remdesivir was initially developed over a decade ago as a potential treatment for hepatitis C and RSV (respiratory syncytial virus). It has also been tested against Ebola, but was beat out by other treatments.

 

According to preliminary results from the Solidarity trial—reported online last week ahead of its planned publication in the New England Journal of Medicine—remdesivir was given to 2,743 patients and their outcomes were compared with those of 2,708 patients given standard treatments. Between the two groups, WHO found that remdesivir did not reduce mortality. It also did not change how many patients progressed to needing mechanical ventilation, nor did it change the proportion of patients discharged after seven days of hospitalization.

 

When the Solidarity trial data was first released, Gilead blasted the results, saying, “The emerging data appear inconsistent with more robust evidence from multiple randomized, controlled studies validating the clinical benefit of [remdesivir].”

Can't fudge this

But in a press conference Friday, the WHO hit back, arguing that the data was, in fact, more robust that the smaller trials that came before it and should certainly be included in any regulatory or clinical decision.

 

“It is the largest trial in the world,” WHO’s chief scientist, Soumya Swaminathan noted. And, unlike the NIAID study, which used a somewhat-subjective clinical scoring system to compare disease progression and a range of definitions for “recovery,” the Solidarity trial compared only clear, indisputable outcomes: mechanical ventilation, discharge from the hospital, and death.

 

“[Death is] not a soft end point,” Swaminathan said. “You cannot fudge that endpoint.”

 

Swaminathan also noted that it was clear that the FDA did not have the Solidarity trial data when it made its decision to approve remdesivir. But, she emphasized that the WHO had provided that data to Gilead in advance. “They first saw the results on the 23^rd of September,” she said, well before it was made public. But,“it appears the results were not considered—not provided to the FDA,” she said.

 

Though the comments suggest the WHO doesn’t support the FDA’s decision to approve remdesivir for treating COVID-19, WHO experts also suggested that the FDA approval may be irrelevant. Instead, expert clinical guidelines for treating patients are what matter most.

 

“Regulatory authorities may place items on an approved list,” WHO Executive Director Michael Ryan said in the press conference. “That doesn’t necessarily mean that they will be used in any particular practice unless they pass into clinical guidance that’s given to doctors and nurses.”

 

The WHO noted that it is working on such clinical guidance and treatment recommendations and expects to release them in three to four weeks.

 

 

Huge COVID study finds remdesivir doesn’t work—FDA grants approval anyway

 

[steven36]

WHO: Nations mulling Gilead's COVID drug should consider trial flop, too

 

 

GENEVA/ZURICH (Reuters) - Health officials reviewing Gilead Science Inc's  remdesivir against COVID-19 should consider all evidence, including a trial in which the medicine failed, before giving it the green light, the top WHO scientist said on Friday.

 

U.S. regulators appeared not to have done so when approving the drug this week, Soumya Swaminathan told a news conference.

 

The U.S. Food and Drug Administration on Thursday approved Gilead’s antiviral drug for treating patients hospitalized with COVID-19, making it the first and only drug approved for the disease in the United States.

 

The FDA decision came a week after the release of the results of the World Health Organization’s Solidarity trial, which concluded remdesivir has little or no impact on a patient’s chances of surviving COVID-19.

 

The FDA said its approval was based on three trials, including a 1,062-patient study by the National Institute of Allergy and Infectious Disease, which found that remdesivir reduced hospital stays to 10 days from 15 days, and helped reduce the risk of death in some patients who were receiving oxygen. The drug did not improve overall survival.

“The Solidarity results do not refute these findings of benefit to patients,” the FDA said in a statement posted on its website.

 

Remdesivir is also approved for treatment of patients with severe COVID-19 in Japan, Taiwan, India, Singapore, the United Arab Emirates and the European Union. Gilead is allowing generic companies to manufacture the drug for supply to 127 low-income countries.

 

“We believe our results are very robust,” the WHO’s Swaminathan said, when asked about the FDA move. “We hope that people who are doing treatment guidelines in other countries, as well as regulators around the world, will take note of our study results, in addition to the other evidence.”

 

For the remdesivir arm of the WHO’s Solidarity trial, 2,743 patients were given the treatment, compared to 2,708 in the control group.

 

Gilead, which has raised the possibility of bias in the “unblinded” WHO study because patients and their doctors were aware of which treatments were being used, got initial data from the trial in late September, the WHO has said.

 

“We have apprised FDA of the topline WHO Solidarity trial results and the draft manuscript” submitted to a publication, the company said. “However, at this time Gilead has not received the requested datasets from WHO for the Solidarity trial results.”

 

The WHO also said on Friday that its formal guidelines on use of remdesivir for COVID-19 should be ready for release in three to four weeks, after a separate group within the United Nations health agency reviews data from the study.

 

An independent WHO panel will convene next week to look at all evidence of the effectiveness of Gilead’s drug, Janet Diaz, the WHO’s top official for clinical care responses, said.

 

“We would anticipate that the guidelines will be available within three to four weeks,” Diaz said. “What we’re doing now in the pandemic is to try to continue with that approach in a transparent and trustworthy way, but do it faster.”

 

Source

[steven36]

It's nothing new  for the FDA to approve  stuff  without  WHO saying it OK Its same as when the FDA approved IQOS Tobacco Heating System earlier  this year

 

 

The WHO said in the statement that the FDA’s decision may be misleading as health may be affected by exposure to some toxins that are present at higher levels in HTP aerosol than in conventional cigarette smoke, as well as additional toxins present in HTP aerosols that are not present in conventional cigarette smoke. The WHO reiterates its recommendation that uses interventions for cessation of all tobacco use, such as nicotine replacement therapies and cessation interventions sent via mobile text messaging.

https://dig.watch/updates/who-issues-statement-us-fdas-decision-regarding-e-cigarette

 

Unless  the USA  Government announces different there leaving WHO here is a update from Sept.

 

The United States has long been the world’s most generous provider of health and humanitarian assistance to people around the world.  This assistance is provided with the support of the American taxpayer with the reasonable expectation that it serve an effective purpose and reach those in need.

 

Unfortunately, the World Health Organization has failed badly by those measures, not only in its response to COVID-19, but to other health crises in recent decades.  In addition, WHO has declined to adopt urgently needed reforms, starting with demonstrating its independence from the Chinese Communist Party.

 

That withdrawal becomes effective on July 6, 2021, and since the President’s announcement, the U.S. government has been working to identify partners to assume the activities previously undertaken by WHO.

 

Today, the United States is announcing the next steps with respect to our withdrawal from the WHO and the redirection of American resources.  This redirection includes reprogramming the remaining balance of its planned Fiscal Year 2020 assessed WHO contributions to partially pay other UN assessments.

 

In addition, through July 2021, the United States will scale down its engagement with the WHO, to include recalling the Department of Health and Human Services (HHS) detailees from WHO headquarters, regional offices, and country offices, and reassigning these experts.  U.S. participation in WHO technical meetings and events will be determined on a case-by-case basis.

 

https://www.state.gov/update-on-u-s-withdrawal-from-the-world-health-organization/