Gilead Chairman: Remdesivir Provided to Over 1,000 Patients, Initial Data Expected Within Weeks

On March 29, Gilead Sciences’ official WeChat account released “An Open Letter from Daniel O’Day, Chairman and CEO of Gilead Sciences, Regarding Remdesivir.”

In an open letter, Daniel O’Day, Chairman and Chief Executive Officer of Gilead Sciences, stated that multiple studies on remdesivir, a potential effective treatment for COVID-19 under the company’s portfolio, are currently underway. “We expect to obtain preliminary data in the coming weeks. If the drug is approved, we will ensure its affordability and accessibility so that patients with urgent needs can access remdesivir.”

According to reports, remdesivir is a drug that Gilead Sciences has been researching for many years. Remdesivir has never been approved for use; however, based on the company’s understanding to date, it may have the potential to treat the novel coronavirus. “Since then, we have been working with the utmost urgency and sense of responsibility to determine whether remdesivir is indeed effective against novel coronavirus pneumonia.”

“Remdesivir is an investigational drug, and it is our responsibility to ensure that it is effective and safe before distributing it for global use,” said Daniel O’Day, adding that the company has been enrolling patients at an unprecedented pace.Clinical Trialreasons.

Meanwhile, Gilead also provides for those unable to participateClinical Trialsprovided this investigational drug to critically ill patients.

The open letter disclosed that the “compassionate use” program is typically reserved for a small number of individual cases, but the current crisis has transcended conventional norms. To date, Gilead has provided remdesivir to more than 1,000 patients. This program, designed by regulatory authorities, requires each application to be reviewed individually on a case-by-case basis. Under normal circumstances, this process functions effectively due to the limited number of applications. However, the system is unable to support and manage the surge in applications encountered during the COVID-19 pandemic.

“To address this issue, we are transitioning to a more streamlined and sustainable approach by expanding the Expanded Access Program. The compassionate use program will be available exclusively to pediatric patients and pregnant women, thereby reducing the volume to a level manageable by the system. Through the Expanded Access Program, hospitals or physicians can simultaneously apply for emergency use of remdesivir for multiple critically ill patients. Although establishing the network of sites requires time, the expanded access approach will ultimately accelerate urgent drug availability for a greater number of patients,” Daniel O’Day disclosed in an open letter. As of yesterday, initial sites in the United States had already become operational, with sites in other countries expected to launch soon.

On March 22, Gilead announced that it would suspend the acceptance of most individual applications for compassionate use of remdesivir by patients with COVID-19, hoping that patients would go throughClinical Trialto receive this investigational drug to determine whether it is safe and effective. At the time, Gilead also stated that pregnant women and minors under 18 years of age who present with severe symptoms of COVID-19 may still apply for “compassionate use” through individual channels.

Remdesivir is an experimental antiviral drug under development by Gilead Sciences, Inc. in the United States; it has not been approved for market release and was previously used to combat Ebola virus infection.Clinical Trial, and it has demonstrated favorable antiviral activity against severe acute respiratory syndrome (SARS) coronavirus and Middle East respiratory syndrome (MERS) coronavirus in vitro and in animal studies.

Since the outbreak of COVID-19, remdesivir has been regarded as the most promising investigational drug. Previously, after investigating the epidemic in China, the World Health Organization stated that remdesivir might be the only effective drug for treating COVID-19. In January this year, based on the principle of “compassionate use,” U.S. researchers administered remdesivir to a patient infected with the novel coronavirus, whose symptoms improved significantly within one to two days, drawing considerable attention to the drug.

Notably, on March 25 (local time), Gilead Sciences issued a statement announcing that it had submitted an application to the U.S. Food and Drug Administration (FDA) requestingFDAWithdraw the orphan drug designation for remdesivir and waive all rights associated with such orphan drug designation.

Following the announcement of its application to withdraw orphan drug designation, Gilead stated in a press release, “Gilead is confident that it can maintain a rapid pace and strive for the earliest possible regulatory approval of remdesivir without orphan drug status. Recent interactions with regulatory authorities have demonstrated that the submission and review processes related to remdesivir for the treatment of COVID-19 are being accelerated.”

Attached is the full text of “Regarding Remdesivir: An Open Letter from Daniel O’Day, Chairman and Chief Executive Officer of Gilead Sciences”:

When news of the coronavirus first emerged, Gilead immediately initiated research into the therapeutic potential of remdesivir. We have conducted extensive research on a broad range of antiviral agents, among which remdesivir has been a focus of our investigation for many years. Although remdesivir had not yet received regulatory approval, based on the knowledge accumulated to date, we recognized its potential as a treatment for the novel coronavirus. Since then, we have worked with the utmost urgency and sense of responsibility to determine whether remdesivir is indeed effective against coronavirus disease 2019 (COVID-19).

This sense of urgency stems from the recognition of patients’ urgent needs and the current lack of any approved treatment options. Remdesivir is an investigational drug, and it is our responsibility to ensure its efficacy and safety before distributing it for global use.

This is also why we have been enrolling patients at an unprecedented pace.Clinical Trialreasons. Collaborating with regulatory authorities to clarify the safety and efficacy of remdesivir is crucial for ensuring broader patient access to this treatment in the future. Several studies are currently underway, and we expect to obtain preliminary data in the coming weeks. If the drug receives approval, we will ensure its affordability and accessibility so that patients with urgent needs can receive remdesivir.

Meanwhile, we also provide for those who are unable to attendClinical Trialsprovided this investigational drug to critically ill patients. The "compassionate use" program is typically reserved for a limited number of individual cases, but the current crisis has transcended conventional boundaries. To date, we have provided remdesivir to more than 1,000 patients. This program, designed by regulatory authorities, requires that each application be reviewed individually on a case-by-case basis. Under normal circumstances, this process functions effectively due to the limited volume of applications. However, the system is unable to support and manage the enormous number of requests encountered during the novel coronavirus pneumonia (COVID-19) pandemic.

To address this issue, we are transitioning to a more streamlined and sustainable approach known as the “Expanded Access” program. The compassionate use program will be restricted solely to pediatric and pregnant patients, thereby reducing the volume to a level manageable by the system. Through the Expanded Access program, hospitals or physicians can simultaneously apply for emergency use of remdesivir for multiple critically ill patients. Although establishing the network of sites requires some time, the Expanded Access approach will ultimately accelerate urgent drug availability for a greater number of patients. As of yesterday, several initial sites in the United States have become operational, and sites in other countries are expected to launch soon.

In recent days, many individuals have reached out to Gilead on behalf of their friends and loved ones to request access to remdesivir. I deeply empathize with those in such difficult circumstances. While we see numbers and statistics reported in the news every day, we recognize that behind each number is a real, heartbreaking human story. When I say, “How much we wish we could help every patient in need,” I speak on behalf of every employee at Gilead. We are currently rapidly establishing an interim expanded access program, while continuing to clarify the potential safety and efficacy of remdesivir and identifying which patients may benefit from its use.

Remdesivir remains an investigational drug, and there is widespread anticipation that it will be proven to be a safe and effective treatment option. We are making corresponding plans based on this expectation—meanwhile, we are also determining whether this is indeed the case in an ethical and responsible manner. At every step of this process, we will make decisions under the guidance of public health institutions and bioethicists, drawing on our decades of experience in providing antiviral treatments for diseases such as human immunodeficiency virus (HIV) and viral hepatitis.

We hope that, by collaborating with numerous groups around the world, we can jointly help patients with novel coronavirus pneumonia (COVID-19). We recognize that the situation is critical, and there is an urgent need to determine whether remdesivir is a safe and effective treatment option.

Our thoughts are with the healthcare workers on the front lines of the epidemic response, who are working around the clock and urgently need effective treatment options. We know that patients and their families worldwide are waiting. Everyone at Gilead is going all out, with a profound sense of urgency and compassion, to fulfill our responsibility with remdesivir.

While continuing to advance the aforementioned efforts, we will also provide timely updates on the latest progress in response to the high level of global public interest in remdesivir. (BioValleyBioon.com）