U.S.’s Food and Drug Administration () is moving to quickly authorize the use of Gilead’s experimental anti-viral drug Remdesivir as an emergency treatment for coronavirus, following news that a preliminary trial of the drug showed positive results.
The study found that patients who took remdesivir recovered faster than patients who did not. Results from the preliminary trial show remdesivir improved recovery time for coronavirus patients from 15 to 11 days.
Gilead Sciences, Inc. announced Wednesday it s results from the open-label, Phase 3 SIMPLE trial evaluating 5-day and 10-day dosing durations of Remdesivir in hospitalized patients with severe manifestations of COVID-19 disease.
The pharmaceutical company says 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”.
Merdad Parsey, the Chief Medical Officer, Gilead Sciences says 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.
Dr Anthony Fauci, the head of U.S.’s National Institute of Allergy and Infectious Diseases was optimistic about the results.
“The data shows that remdesivir has a clear-cut, significant, positive effect in diminishing the time to recovery,” Dr. Anthony Fauci said at the White House during a meeting with President Donald Trump.
“Although a 31% improvement doesn’t seem like a knockout 100%, it is very important proof of concept. What it has proven is that a drug can block this virus,” Dr Fauci added.
The study by Gilead Science 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.
FDA has not yet approved any drugs for the treatment of the coronavirus. But it plans to announce an emergency-use authorization for remdesivir, according to The New York Times.
In a statement to CNN, the FDA said it is in talks with Gilead Sciences, the maker of remdesivir, about making the drug available to patients.
“As part of the FDA’s commitment to expediting the development and availability of potential COVID-19 treatments, the agency has been engaged in … discussions with Gilead Sciences regarding making remdesivir available to patients as quickly as possible, as appropriate,” FDA spokesman Michael Felberbaum said in statement.
Impact of Earlier Treatment
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 and acute respiratory failure.