$辉瑞(PFE)$FDA NEWS RELEASE

Coronavirus (**) Update: FDA Continues to Facilitate Development of Treatments

The U.S. Food and Drug Administration continues to play a critical role in the multifaceted all-of-government response to the ** 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 **.

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 ** 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 **.

“President Trump’s aggressive response and bold actions to keep Americans safe from ** 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 **.

“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 **-related therapies. We understand and recognize the urgency with which we are all seeking prevention and treatment options for **. 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 **, 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 **, 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 **, 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 ** 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 ** patients with the investigational antiviral drug remdesivir. The FDA has been working with the drug sponsor, Gilead Sciences Inc.External Link Disclaimer, 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 ** 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 ** patients, thereby potentially slowing the progression of severe respiratory symptoms. Regeneron Pharmaceuticals Inc.External Link Disclaimer 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 ** 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 ** 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 **.

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 **. 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 ** as part of the agency’s around-the-clock response to this outbreak.

The FDA, an agency within the U.S. Department of Health and Human Services, protects the public health by assuring the safety, effectiveness, and security of human and veterinary drugs, vaccines and other biological products for human use, and medical devices. The agency also is responsible for the safety and security of our nation’s food supply, cosmetics, dietary supplements, products that give off electronic radiation, and for regulating tobacco products.