-- Expands Previous Authorization of Veklury to Treat Hospitalized Patients with COVID-19 Regardless of Oxygen Status --
Gilead Sciences, Inc. (Nasdaq: GILD) today announced the U.S. Food and Drug Administration (FDA) expanded the Emergency Use Authorization (EUA) enabling use of the investigational antiviral Veklury® (remdesivir) to treat all hospitalized patients with COVID-19, in addition to the previous authorization for patients hospitalized with severe COVID-19. The expanded EUA is based on results from the Phase 3 SIMPLE trial evaluating Veklury in hospitalized patients with moderate COVID-19 pneumonia, as well as results from the National Institute of Allergy and Infectious Diseases (NIAID) ACTT-1 trial in hospitalized patients with a range of disease severity.
"With the growing understanding of the utility of Veklury to help improve outcomes for a range of patients with COVID-19, we welcome the FDA’s decision to expand emergency use authorization," said Merdad Parsey, MD, PhD, Chief Medical Officer, Gilead Sciences. "As we learn more about COVID-19 and we further establish the efficacy and safety profile of Veklury, we see benefit to making the drug available to patients at earlier stages of the disease. Today’s action by the FDA enables physicians to consider a broader range of eligible patients to potentially receive Veklury."
Results from the Phase 3 SIMPLE study were published in the Journal of the American Medical Association (JAMA) on August 21, 2020 and confirm top-line results previously announced on June 1, 2020. The primary endpoint evaluated patients at Day 11 on a 7-point ordinal scale and found patients randomized to a 5-day course of Veklury plus standard of care were 65 percent more likely to have an improvement in clinical status compared with those randomized to standard of care alone (OR, 1.65; 95% confidence interval, 1.09-2.48; p=0.017). For patients in the 10-day Veklury group, the improvement in clinical status at Day 11 was not statistically different compared with the standard of care group (OR, 1.31; 95% confidence interval, 0.88-1.95; p=0.183).
"As our understanding of the spectrum of SARS-CoV-2 infection and the presentations and severity of COVID-19 continues to evolve, these results and the expanded EUA represent a new, important step that streamlines bedside prescribing of remdesivir without having to wait for patients to worsen clinically," said Francisco Marty, MD, an infectious diseases physician at Brigham and Women’s Hospital, and associate professor of medicine at Harvard Medical School. "These study results show that patients with moderate COVID-19 disease may also benefit from a 5-day treatment course of remdesivir."
The data published in JAMA demonstrate that Veklury was generally well-tolerated in both the 5-day and 10-day treatment groups. The most commonly reported adverse events in the 5-day, 10-day, and standard of care groups, respectively, were nausea (10% vs 9% vs 3%), diarrhea (6% vs 5% vs 7%), hypokalemia (5% vs 7% vs 2%), and headache (5% vs 5% vs 3%). All-cause mortality at Day 28 was ≤ 2% in all treatment groups.
Please see below for additional important warnings and information about the authorized use of Veklury in the United States. In the United States, Veklury is an investigational drug that has not been approved by the FDA, and the safety and efficacy of Veklury for the treatment of COVID-19 have not been established.
About the SIMPLE Trials
Gilead initiated two randomized, open-label, multi-center international Phase 3 clinical trials for Veklury, the SIMPLE studies, in countries with a high prevalence of COVID-19 infections.
The first SIMPLE trial is evaluating the safety and efficacy of 5-day and 10-day dosing durations of Veklury administered intravenously in hospitalized patients with severe manifestations of COVID-19. The initial phase of the study randomized 397 patients in a 1:1 ratio to receive either a 5-day or a 10-day treatment course of Veklury in addition to standard of care. Moderate disease was defined in the study as any radiographic evidence of pulmonary infiltrates and oxygen saturation >94% on room air. An expansion phase of the study was added to enroll up to 5,600 additional patients, including those on mechanical ventilation.
The second SIMPLE trial is evaluating the safety and efficacy of 5-day and 10-day dosing durations of Veklury administered intravenously in hospitalized patients with moderate manifestations of COVID-19, compared with standard of care. The initial phase of the study randomized 600 patients in a 1:1:1 ratio to receive either a 5-day or a 10-day treatment course of Veklury in addition to standard of care, compared with standard of care alone. An expansion phase of the study was added to enroll up to 1,000 additional patients with moderate disease.
About Veklury (remdesivir)
Veklury is an investigational nucleotide analog with broad-spectrum antiviral activity both in vitro and in vivo in animal models against multiple emerging viral pathogens. Multiple ongoing international Phase 3 clinical trials are evaluating the safety and efficacy of Veklury for the treatment of SARS-CoV-2 infection, the virus that causes COVID-19, in different patient populations, formulations, and in combination with other therapies.
Important Information about Veklury in the United States
In the United States, Veklury (remdesivir) is authorized for use under an Emergency Use Authorization (EUA) only for the treatment of hospitalized adult and pediatric patients with suspected or laboratory-confirmed COVID-19. Veklury must be administered via intravenous (IV) infusion and is supplied two ways: Veklury (remdesivir) for injection, 100 mg, lyophilized powder, or Veklury (remdesivir) injection, 100 mg/20 mL (5 mg/mL), concentrated solution.
Veklury is an investigational drug that has not been approved by the FDA for any use, and the safety and efficacy of Veklury for the treatment of COVID-19 have not been established. This authorization is temporary and may be revoked, and does not take the place of the formal new drug application submission, review and approval process. For information about the authorized use of Veklury and mandatory requirements of the EUA in the U.S., please review the Fact Sheets and FDA Letter of Authorization available at www.gilead.com/remdesivir.
There are limited clinical data available for Veklury. Serious and unexpected adverse events may occur that have not been previously reported with Veklury use. Hypersensitivity reactions, including infusion-related and anaphylactic reactions, have been observed during and following administration of Veklury. The use of Veklury is contraindicated in patients with known hypersensitivity to Veklury. Transaminase elevations have been observed in healthy volunteers and patients with COVID-19 in clinical trials who received Veklury. Patients should have appropriate clinical and laboratory monitoring to aid in early detection of any potential adverse events. Monitor renal and hepatic function prior to initiating and daily during therapy with Veklury; additionally monitor serum chemistries and hematology daily during therapy. Do not initiate Veklury in patients with ALT ≥5x ULN or with an eGFR <30 mL/min. The decision to continue or discontinue Veklury therapy after development of an adverse event should be made based on the clinical risk/benefit assessment for the individual patient.
Due to a risk of reduced antiviral activity, coadministration of Veklury and chloroquine phosphate or hydroxychloroquine sulfate is not recommended.
Healthcare providers and/or their designee are responsible for mandatory FDA MedWatch reporting of all medication errors and serious adverse events or deaths occurring during Veklury treatment and considered to be potentially attributable to Veklury. These events must be reported within 7 calendar days from the onset of the event. MedWatch adverse event reports can be submitted to FDA online at www.fda.gov/medwatch or by calling 1-800-FDA-1088.
About Gilead Sciences
Gilead Sciences, Inc. is a research-based biopharmaceutical company that discovers, develops and commercializes innovative medicines in areas of unmet medical need. The company strives to transform and simplify care for people with life-threatening illnesses around the world. Gilead has operations in more than 35 countries worldwide, with headquarters in Foster City, California.
For more information on Gilead’s response to the coronavirus outbreak please visit the company’s dedicated page: https://www.gilead.com/purpose/advancing-global-health/covid-19.
This press release includes forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995 that are subject to risks, uncertainties and other factors. Veklury is an investigational drug that has not been approved by the FDA for any use, and it is not yet known if Veklury is safe or effective for the treatment of COVID-19. There is the possibility of unfavorable results from ongoing and additional clinical trials involving Veklury and the possibility that Gilead and other parties may be unable to complete one or more of such trials in the currently anticipated timelines or at all. Further, it is possible that Gilead may make a strategic decision to discontinue development of Veklury or that FDA and other regulatory agencies may not approve Veklury, and any marketing approvals, if granted, may have significant limitations on its use. As a result, Veklury may never be successfully commercialized. These risks, uncertainties and other factors could cause actual results to differ materially from those referred to in the forward-looking statements. The reader is cautioned not to rely on these forward-looking statements. These and other risks are described in detail in Gilead’s Quarterly Report on Form 10-Q for the quarter ended June 30, 2020, as filed with the U.S. Securities and Exchange Commission. All forward-looking statements are based on information currently available to Gilead, and Gilead assumes no obligation to update any such forward-looking statements.
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Douglas Maffei, PhD, Investors
Amy Flood, Media