• Skip to main content
  • Skip to secondary menu
  • Skip to footer

Press Media Release

press release distribution

  • Submit a Press Release
  • Market Wire
  • Make a Contribution
  • About
    • Template for press/media release
  • Contact

Coronavirus (COVID-19) Update: FDA Continues to Facilitate Development of Treatments

March 19, 2020 By admin Leave a Comment

The U.S. Food and Drug Administration continues to play a critical role in the multifaceted all-of-government response to the COVID-19 pandemic, which includes, among other things, facilitating medical countermeasures to treat and prevent the disease, and surveilling the medical product and food supply chains for potential shortages or disruptions and helping to mitigate such impacts, as necessary.

As part of those efforts, President Trump has directed the FDA to continue its work with the public and private sector to ensure the availability of potentially safe and effective life-saving drugs to patients who are in desperate need, including those infected with COVID-19.

The FDA has been working closely with other government agencies and academic centers that are investigating the use of the drug chloroquine, which is already approved for treating malaria, lupus and rheumatoid arthritis, to determine whether it can be used to treat patients with mild-to-moderate COVID-19 to potentially reduce the duration of symptoms, as well as viral shedding, which can help prevent the spread of disease. Studies are underway to determine the efficacy in using chloroquine to treat COVID-19.

“President Trump’s aggressive response and bold actions to keep Americans safe from COVID-19 bought us precious time to advance therapeutics and other necessary tools,” said HHS Secretary Alex Azar. “Today’s actions show that HHS and the United States are leading the world in these efforts. Disseminating information about promising off-label uses of drugs we already have, investigating their effectiveness, and pursuing other therapeutics will help give American healthcare providers the tools they need to save lives. As we have always seen when America has faced a serious threat, American industry, academic institutions and government are coming together to deliver us what we need to win.”

The FDA wants to assure the American public that the agency continues to work with partners across the U.S. government and regulated industry to expedite the development and availability of critical medical products to prevent and treat this novel virus, including repurposing existing therapies that may help treat patients with COVID-19.

“As is true for most medical situations, the great American innovators in academia and industry have engaged with us about treatment options. We are extremely encouraged by the interest and promise in the development of the COVID-19-related therapies. We understand and recognize the urgency with which we are all seeking prevention and treatment options for COVID-19. FDA staff are working expeditiously on that front,” said FDA Commissioner Stephen Hahn, M.D. “We also must ensure these products are effective; otherwise we risk treating patients with a product that might not work when they could have pursued other, more appropriate, treatments. At the same time, we will engage with domestic manufacturers to ramp up production of this product to mitigate any potential supply chain pressures. If clinical data suggests this product may be promising in treating COVID-19, we know there will be increased demand for it. We will take all steps to ensure chloroquine remains available for patients who take it to treat severe and life-threatening illnesses such as lupus.”

While there are no FDA-approved therapeutics or drugs to treat, cure or prevent COVID-19, there are several FDA-approved treatments that may help ease the symptoms from a supportive care perspective.

The FDA is working closely with innovators in their work to expedite these efforts, including leveraging scientific information about the virus and trials currently being conducted in other countries such as China, Japan, South Korea and Italy as well as in the U.S.

Quickly after the emergence of this virus, the FDA began working directly with partners and innovators to foster the development of medical countermeasures against COVID-19, and we are continuing to provide regulatory flexibility, advice, guidance, and technical assistance. The FDA continues to work with interested sponsors to help expedite any additional clinical trials for COVID-19 medical countermeasures that may be appropriate. The FDA is able to, and has been, turning around requests very quickly to assist in initiating clinical trials.

For example, last month, the National Institutes of Health (NIH) began a randomized controlled trial for the treatment of COVID-19 patients with the investigational antiviral drug remdesivir. The FDA has been working with the drug sponsor, Gilead Sciences Inc., to find multiple pathways to both study the drug under the FDA’s investigational new drug requirements, and thus collect helpful data about the efficacy of the drug, as well as provide the drug to patients under emergency use. The FDA is committed to continuing to make use of its expanded access program to allow the emergency use of this product for those patients, when appropriate. To date, the agency has already granted about 250 patients access to this product. The data collected from the expanded access program may contribute to the agency’s understanding of the drug, but controlled clinical trials are needed to determine if it safe and effective for the treatment of COVID-19 infection.

The FDA’s efforts to facilitate the development of these therapies are squarely focused on ensuring these medical countermeasures meet the agency’s world-respected gold standard, relying on data from adequate and well-controlled trials to most efficiently determine if an experimental treatment can safely and effectively benefit patients.

Innovators are looking at products in a variety of areas, including the assessment of antiviral drugs that might treat the specific virus, as well as host targets, such as interleukin-6 (IL-6) receptor inhibitors that may be helpful in reducing lung inflammation and improving lung function in COVID-19 patients, thereby potentially slowing the progression of severe respiratory symptoms. Regeneron Pharmaceuticals Inc. has announced the initiation of a randomized controlled clinical trial of sarilumab, an antibody to the IL-6 receptor, to assess whether the modification of the inflammatory response by this treatment provides benefit to COVID-19 patients.

There’s also interest in evaluating whether therapies, such as convalescent plasma and hyperimmune globulin, antibody-rich blood products that are taken from blood donated by people who have recovered from the virus, could shorten the length, or lessen the severity, of the illness. The FDA is taking the lead on an urgent cross-government approach to facilitate the development of all of these products. Facilitating the ultimate widespread use and availability of safe and effective medical countermeasures is critical for a number of reasons, including that reducing the severity and duration of respiratory or other symptoms through medical treatments could help lessen the burden on medical personnel, equipment, and facilities.

At the same time, the FDA will continue work to facilitate the development of treatment options in the near-term, the agency is also working with interagency partners, product developers, and international public health organizations to expedite the development of vaccines to the greatest extent possible. In fact, earlier this week, NIH announced the start of a Phase 1 clinical trial in Seattle in 45 healthy adult volunteers to test the safety of an investigational vaccine designed to protect against COVID-19 infection. The FDA intends to use all of the regulatory flexibility granted to it by Congress to ensure the most efficient and timely development of vaccines to fight COVID-19.

As agency staff work around the clock to facilitate prevention and treatment options, it’s extremely important for everyone to know that people may try to make claims about products that are not approved – and don’t have data supporting efficacy – in preventing, treating or diagnosing COVID-19. The FDA is closely monitoring the market to combat these products with fraudulent claims. It is unacceptable that anyone would take advantage of Americans during this public health crisis, and the FDA wants to make sure everyone knows what legitimate products are being developed.

The FDA remains steadfast in helping to foster the development of safe and effective medical countermeasures and ensuring they are available as quickly as possible to protect public health and safeguarding Americans from fraudulent products claiming to prevent, treat, or diagnose COVID-19 as part of the agency’s around-the-clock response to this outbreak.

SOURCE U.S. Food and Drug Administration
http://www.fda.gov

Filed Under: Press Release Tagged With: COVID-19, Coronavirus

Reader Interactions

Leave a Reply Cancel reply

Your email address will not be published. Required fields are marked *

Footer

Recent Posts

  • The Role of Forests in Climate Change Mitigation
  • U.S. Department of State, Bezos Earth Fund, and Rockefeller Foundation Announce Next Steps on Energy Transition Accelerator
  • Social Media Digest
  • COVID-19 Claims 2,000 Lives Per Week; 3 Critical Things Everyone Should Know
  • Economic Uncertainty Rising, 83% of Marketing Leaders to Prioritize Investments in Operational Efficiency and Hiring in 2023
  • PXEF.com adds new AI painting to art gallery: “Rich girl, poor girl in the swimming pool”
  • Market Research Media releases new market research report on the U.S. government market for low-code/no-code software
  • XRY, the MSAB extraction solution, comes with new features centered on ensuring the chain of custody of digital evidence
  • Ultisim Announces Advisory Board
  • Exclusive.org Announces Sale of Exclusive Domains

Media Partners

  • VPNW.com
  • OPINT
  • Digital Market
Give people time to recover
As a technical writer, it’s pretty common to do the thing you’re documenting
The “peanut butter method” does not work
Picasso quote: When art critics get together…
How do we judge the information we meet?
Domains of the Day: AfricanInvesting.com
Spotivity Closes $1M Seed Funding Round
Hammoq Raises $3M Seed Financing
Joystick raises $8M to turn gamers into owners and content creators
Palliare Completes $8m Series A Funding Round
ClayStack Liquid Staking Protocol Raises $5.2 Million in Seed Funding Co-Led by CoinFund and ParaFi Capital
Moonshot Commons Raised Seed Round from HashKey Capital to “break geo-barriers” for the next Gen-Z founders in Web3
Domains of the day: CodingFree.io
Holaplex Announces $6 Million Seed Round to Empower Independent Creators of NFTs
Test your crypto knowledge with this quiz

Media Partners

  • Media Instances
  • PXEF.com
  • S3H.com
Kaleidoscopic work of English abstract artist Bridget Riley on full display in the U.S.
The use cases for the metaverse are easy to spot and multiplying fast
Sony Launching New Social Media Campaign, “U THE WORLDBUILDER”: “Discover Extraordinary World around You,” Collaborative Photography Project with Finn Wolfhard
Want to learn more about Impressionist painter, Eva Gonzalès?
Perfectionism is associated with a string of mental-health disorders
In Memory of Mishmish
Pedestrians walking on a busy street in urban landscape
The Phyron Effect: State-Of-The-Art AI Videos Proven To Drive 50% More Potential Customers to Car Ads
Tomorrow.Mobility moves forward
Neither of these images are photographs
Join Our Team at S3H.com Consulting - A One-Stop Shop for Technology Solutions
The age of globalization isn’t returning any time soon
Is Industry 4.0 a fad that already has been forgotten?
What is the role of religion in the modern world
The Science of Dreams: Generative AI can drastically boost productivity by automating routine tasks

Copyright © 2022 PressMediaRelease.com

Sponsored by Exclusive Domains

We use cookies on our website to give you the most relevant experience by remembering your preferences and repeat visits. By clicking “Accept”, you consent to the use of ALL the cookies.
Do not sell my personal information.
Cookie SettingsAccept
Manage consent

Privacy Overview

This website uses cookies to improve your experience while you navigate through the website. Out of these, the cookies that are categorized as necessary are stored on your browser as they are essential for the working of basic functionalities of the website. We also use third-party cookies that help us analyze and understand how you use this website. These cookies will be stored in your browser only with your consent. You also have the option to opt-out of these cookies. But opting out of some of these cookies may affect your browsing experience.
Necessary
Always Enabled
Necessary cookies are absolutely essential for the website to function properly. These cookies ensure basic functionalities and security features of the website, anonymously.
CookieDurationDescription
cookielawinfo-checkbox-analytics11 monthsThis cookie is set by GDPR Cookie Consent plugin. The cookie is used to store the user consent for the cookies in the category "Analytics".
cookielawinfo-checkbox-analytics11 monthsThis cookie is set by GDPR Cookie Consent plugin. The cookie is used to store the user consent for the cookies in the category "Analytics".
cookielawinfo-checkbox-functional11 monthsThe cookie is set by GDPR cookie consent to record the user consent for the cookies in the category "Functional".
cookielawinfo-checkbox-functional11 monthsThe cookie is set by GDPR cookie consent to record the user consent for the cookies in the category "Functional".
cookielawinfo-checkbox-necessary11 monthsThis cookie is set by GDPR Cookie Consent plugin. The cookies is used to store the user consent for the cookies in the category "Necessary".
cookielawinfo-checkbox-necessary11 monthsThis cookie is set by GDPR Cookie Consent plugin. The cookies is used to store the user consent for the cookies in the category "Necessary".
cookielawinfo-checkbox-others11 monthsThis cookie is set by GDPR Cookie Consent plugin. The cookie is used to store the user consent for the cookies in the category "Other.
cookielawinfo-checkbox-others11 monthsThis cookie is set by GDPR Cookie Consent plugin. The cookie is used to store the user consent for the cookies in the category "Other.
cookielawinfo-checkbox-performance11 monthsThis cookie is set by GDPR Cookie Consent plugin. The cookie is used to store the user consent for the cookies in the category "Performance".
cookielawinfo-checkbox-performance11 monthsThis cookie is set by GDPR Cookie Consent plugin. The cookie is used to store the user consent for the cookies in the category "Performance".
viewed_cookie_policy11 monthsThe cookie is set by the GDPR Cookie Consent plugin and is used to store whether or not user has consented to the use of cookies. It does not store any personal data.
viewed_cookie_policy11 monthsThe cookie is set by the GDPR Cookie Consent plugin and is used to store whether or not user has consented to the use of cookies. It does not store any personal data.
Functional
Functional cookies help to perform certain functionalities like sharing the content of the website on social media platforms, collect feedbacks, and other third-party features.
Performance
Performance cookies are used to understand and analyze the key performance indexes of the website which helps in delivering a better user experience for the visitors.
Analytics
Analytical cookies are used to understand how visitors interact with the website. These cookies help provide information on metrics the number of visitors, bounce rate, traffic source, etc.
Advertisement
Advertisement cookies are used to provide visitors with relevant ads and marketing campaigns. These cookies track visitors across websites and collect information to provide customized ads.
Others
Other uncategorized cookies are those that are being analyzed and have not been classified into a category as yet.
SAVE & ACCEPT