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Breaking: U.S. Regulators Approves 'remdesivir' As Coronavirus Treatment Drug - Foreign Affairs - Nairaland

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Breaking: U.S. Regulators Approves 'remdesivir' As Coronavirus Treatment Drug by Newsblenda(m): 6:39am On May 02, 2020
Remdesivir a broad-spectrum anti-viral medication developed by biopharmaceutical company Gilead Sciences has been approved as a possible treatment drugs for Covid-19.

U.S. Food and Drug Administration (FDA) okays the emergency use of the experimental drug remdesivir, because it has shown great results after being administered to some hospitalized coronavirus patients and so far it helps them recover faster.

Donald Trump made the announcement during a meeting with Gilead chief executive Daniel O'Day on Friday at the white house oval office.

In his speech, the maker of the drug Mr O'Day called the move a significant step towards easing the coronavirus crisis.

"We're humbled by this being an important first step for ... hospitalised patients," Mr O'Day said.

"We want to make sure nothing gets in the way of these patients getting the medicine, so we made a decision to donate about 1.5 million vials."


https://www.youtube.com/watch?v=gQlkjPOQNM4
Currently there is no W.H.O. approved treatment drugs for coronavirus, and remdesivir will still need formal approval. The regulators can convert the drug’s status to full approval if Gilead or other researchers provide additional data of remdesivir’s safety and effectiveness.

Source: https://www.newsblenda.com/post/entertainment/breaking-u-s-regulators-approves-remdesivir-as-coronavirus-treatment-drug.html

Re: Breaking: U.S. Regulators Approves 'remdesivir' As Coronavirus Treatment Drug by rawpadgin(m): 6:40am On May 02, 2020
Good news
Re: Breaking: U.S. Regulators Approves 'remdesivir' As Coronavirus Treatment Drug by uchaymart(m): 6:42am On May 02, 2020
Glory to God in the Highest.

1 Like

Re: Breaking: U.S. Regulators Approves 'remdesivir' As Coronavirus Treatment Drug by Newsblenda(m): 6:48am On May 02, 2020
Exactly
Re: Breaking: U.S. Regulators Approves 'remdesivir' As Coronavirus Treatment Drug by Nobody: 6:49am On May 02, 2020
Made by a Nigerian Doctor
A Yoruba Doctor living in Chicago

2 Likes

Re: Breaking: U.S. Regulators Approves 'remdesivir' As Coronavirus Treatment Drug by Nobody: 6:57am On May 02, 2020
EastGold:
Made by a Nigerian Doctor
A Yoruba Doctor living in Chicago

Dont be tribal this morning biko..

A Nigerian Doctor is ok

4 Likes

Re: Breaking: U.S. Regulators Approves 'remdesivir' As Coronavirus Treatment Drug by Nobody: 7:02am On May 02, 2020
chuksbaby:


Dont be tribal this morning biko..

A Nigerian Doctor is ok

The way your people would have shouted igbo amaka
Re: Breaking: U.S. Regulators Approves 'remdesivir' As Coronavirus Treatment Drug by Getoverit1: 7:03am On May 02, 2020
EastGold:
Made by a Nigerian Doctor
A Yoruba Doctor living in Chicago

chuksbaby:


Dont be tribal this morning biko..

A Nigerian Doctor is ok

Fake news and naija be like 5&6

Remdesivir was created and developed by Gilead Sciences, under the direction of scientist Tomáš Cihlář who is an Czech American .

Google it if you don't believe it .

4 Likes

Re: Breaking: U.S. Regulators Approves 'remdesivir' As Coronavirus Treatment Drug by Nobody: 7:05am On May 02, 2020
Getoverit1:




Fake news and naija be like 5&6

Remdesivir was created and developed by Gilead Sciences, under the direction of scientist Tomáš Cihlář.


smiley smiley smiley

Out of tribal hatred, you will disgrace yourself this morning

2 Likes

Re: Breaking: U.S. Regulators Approves 'remdesivir' As Coronavirus Treatment Drug by Newsblenda(m): 7:05am On May 02, 2020
Which kind Nigeria doctor?

2 Likes

Re: Breaking: U.S. Regulators Approves 'remdesivir' As Coronavirus Treatment Drug by Nobody: 7:06am On May 02, 2020
Getoverit1:




Fake news and naija be like 5&6

Remdesivir was created and developed by Gilead Sciences, under the direction of scientist Tomáš Cihlář who is an Czech American .

Google it if you don't believe it .


i know, just advice to the tribal comment

1 Like

Re: Breaking: U.S. Regulators Approves 'remdesivir' As Coronavirus Treatment Drug by Newsblenda(m): 7:11am On May 02, 2020
All this people talking about Yoruba self are funny

1 Like

Re: Breaking: U.S. Regulators Approves 'remdesivir' As Coronavirus Treatment Drug by leokid866: 7:16am On May 02, 2020
EastGold:
Made by a Nigerian Doctor
A Yoruba Doctor living in Chicago
Not actually made by the doctor. Dr. Babefemi Taiwo is just the lead scientists in the drug test by the National Institute of Health. But I will say it is his recommendations that the government will listen to in terms of its application.
Re: Breaking: U.S. Regulators Approves 'remdesivir' As Coronavirus Treatment Drug by Nobody: 7:19am On May 02, 2020
leokid866:

Not actually made by the doctor. Dr. Babefemi Taiwo is just the lead scientists in the drug test by the National Institute of Health. But I will say it is his recommendations that the government will listen to in terms of its application.

Abeg I no get time for argument
Re: Breaking: U.S. Regulators Approves 'remdesivir' As Coronavirus Treatment Drug by leokid866: 7:26am On May 02, 2020
EastGold:


Abeg I no get time for argument
Just Google it's not hard.

2 Likes

Re: Breaking: U.S. Regulators Approves 'remdesivir' As Coronavirus Treatment Drug by thinkaxis(m): 7:28am On May 02, 2020
good news
Re: Breaking: U.S. Regulators Approves 'remdesivir' As Coronavirus Treatment Drug by Nogan1: 7:57am On May 02, 2020
Press release from Gilead Sciences Inc

Gilead Announces Results From Phase 3 Trial of Investigational Antiviral Remdesivir in Patients With Severe COVID-19

-- Study Demonstrates Similar Efficacy with 5- and 10-Day Dosing Durations of Remdesivir --

Merdad Parsey, MD, PhD, Chief Medical Officer, Gilead Sciences

Aruna Subramanian, MD, Clinical Professor of Medicine, Chief, Immunocompromised Host Infectious Diseases, Stanford University School of Medicine, and lead investigators of the study.



FOSTER CITY, Calif.--(BUSINESS WIRE)--Apr. 29, 2020-- Gilead Sciences, Inc. (Nasdaq: GILD) today announced topline results from the open-label, Phase 3 SIMPLE trial evaluating 5-day and 10-day dosing durations of the investigational antiviral remdesivir in hospitalized patients with severe manifestations of COVID-19 disease. The study demonstrated that patients receiving a 10-day treatment course of remdesivir achieved similar improvement in clinical status compared with those taking a 5-day treatment course (Odds Ratio: 0.75 [95% CI 0.51 – 1.12] on Day 14). No new safety signals were identified with remdesivir across either treatment group. Gilead plans to submit the full data for publication in a peer-reviewed journal in the coming weeks.

“Unlike traditional drug development, we are attempting to evaluate an investigational agent alongside an evolving global pandemic. Multiple concurrent studies are helping inform whether remdesivir is a safe and effective treatment for COVID-19 and how to best utilize the drug,” said Merdad Parsey, MD, PhD, Chief Medical Officer, Gilead Sciences.

“These study results complement data from the placebo-controlled study of remdesivir conducted by the National Institute for Allergy and Infectious Diseases and help to determine the optimal duration of treatment with remdesivir. The study demonstrates the potential for some patients to be treated with a 5-day regimen, which could significantly expand the number of patients who could be treated with our current supply of remdesivir. This is particularly important in the setting of a pandemic, to help hospitals and healthcare workers treat more patients in urgent need of care.”

Remdesivir is not yet licensed or approved anywhere globally and has not yet been demonstrated to be safe or effective for the treatment of COVID-19. This study sought to determine whether a shorter, 5-day course of remdesivir would achieve similar efficacy results as the 10-day treatment regimen used in multiple ongoing studies of remdesivir. Secondary objectives included rates of adverse events and additional measures of clinical response in both treatment groups. Patients were required to have evidence of pneumonia and reduced oxygen levels that did not require mechanical ventilation at the time of study entry. Clinical improvement was defined as an improvement of two or more points from baseline on a predefined seven-point scale, ranging from hospital discharge to increasing levels of oxygen support to death. Patients achieved clinical recovery if they no longer required oxygen support and medical care or were discharged from the hospital.

In this study, the time to clinical improvement for 50 percent of patients was 10 days in the 5-day treatment group and 11 days in the 10-day treatment group. More than half of patients in both treatment groups were discharged from the hospital by Day 14 (5-day: 60.0%, n=120/200 vs.10-day: 52.3% n=103/197; p=0.14). At Day 14, 64.5 percent (n=129/200) of patients in the 5-day treatment group and 53.8 percent (n=106/197) of patients in the 10-day treatment group achieved clinical recovery.

Clinical outcomes varied by geography. Outside of Italy, the overall mortality rate at Day 14 was 7 percent (n=23/320) across both treatment groups, with 64 percent (n=205/320) of patients experiencing clinical improvement at Day 14 and 61 percent (n=196/320) of patients discharged from the hospital.

In an exploratory analysis, patients in the study who received remdesivir within 10 days of symptom onset had improved outcomes compared with those treated after more than 10 days of symptoms. Pooling data across treatment arms, by Day 14, 62 percent of patients treated early were able to be discharged from the hospital, compared with 49 percent of patients who were treated late.

“These data are encouraging as they indicate that patients who received a shorter, 5-day course of remdesivir experienced similar clinical improvement as patients who received a 10-day treatment course,” said Aruna Subramanian, MD, Clinical Professor of Medicine, Chief, Immunocompromised Host Infectious Diseases, Stanford University School of Medicine, and one of the lead investigators of the study.


“While additional data are still needed, these results help to bring a clearer understanding of how treatment with remdesivir may be optimized, if proven safe and effective.”

Remdesivir was generally well-tolerated in both the 5-day and 10-day treatment groups. The most common adverse events occurring in more than 10 percent of patients in either group were nausea (5-day: 10.0%, n=20/200 vs. 10-day: 8.6%, n=17/197) and acute respiratory failure (5-day: 6.0%, n=12/200 vs. 10-day: 10.7%, n= 21/197). Grade 3 or higher liver enzyme (ALT) elevations occurred in 7.3 percent (n=28/385) of patients, with 3.0 percent (n=12/397) of patients discontinuing remdesivir treatment due to elevated liver tests.

1 Like

Re: Breaking: U.S. Regulators Approves 'remdesivir' As Coronavirus Treatment Drug by Nogan1: 8:17am On May 02, 2020
Getoverit1:




Fake news and naija be like 5&6

Remdesivir was created and developed by Gilead Sciences, under the direction of scientist Tomáš Cihlář who is an Czech American .

Google it if you don't believe it .


i tire too oo undecided

1 Like

Re: Breaking: U.S. Regulators Approves 'remdesivir' As Coronavirus Treatment Drug by shegemenge(m): 8:43am On May 02, 2020
Can they just approve the drug or vaccine
and ship it to Africa already. I'm damn tired of this lockdown!
Re: Breaking: U.S. Regulators Approves 'remdesivir' As Coronavirus Treatment Drug by malawian0000001: 10:29am On May 02, 2020
Hold on.... So Oyimbo man create drug, then Ypruba an follow the people wey dey test the drug on patients... Yoruba peeps come say na Yoruba man create the drug. grin grin

You can't make these things up.

1 Like

Re: Breaking: U.S. Regulators Approves 'remdesivir' As Coronavirus Treatment Drug by Newsblenda(m): 6:56am On May 04, 2020
cheesy

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