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Photo: Researcher from Gilead’s website
Remdesivir approved by FDA
Johns Hopkins MD’s vision for a “near cure”
Right along with the bad news of rising numbers of positives and hospitalizations, two events happened which put us back into hope for the immediate future of dealing with the coronavirus.
Late Friday, the FDA announced their approval of Remdesivir – Gilead’s antiviral known clinically as Veklury – for treatment of appropriate patients with COVID-19. Up until now Remdesivir was only available for emergency use – and came into the spotlight when it was used as part of the treatment regimen for the president of the United States.
Here is the announcement from Gilead:
U.S. Food and Drug Administration Approves Gilead’s Antiviral Veklury® (remdesivir) for Treatment of COVID-19 – First and Only FDA-Approved Treatment for COVID-19 in the United States — Shortens Time to Recovery By Five Days in Hospitalized COVID-19 Patients
Gilead Sciences, Inc. today announced that the U.S. Food and Drug Administration (FDA) has approved the antiviral drug Veklury® (remdesivir) for the treatment of patients with COVID-19 requiring hospitalization. As an antiviral drug, Veklury works to stop replication of SARS-CoV-2, the virus that causes COVID-19. Previously authorized by the FDA for emergency use to treat COVID-19, Veklury is now the first and only approved COVID-19 treatment in the United States. The drug is now widely available in hospitals across the country, following early investments to rapidly expand manufacturing capacity to increase supply.
In the United States, Veklury is indicated for adults and pediatric patients (12 years of age and older and weighing at least 40 kg) for the treatment of COVID-19 requiring hospitalization. Veklury should only be administered in a hospital or in a healthcare setting capable of providing acute care comparable to inpatient hospital care. Veklury is contraindicated in patients who are allergic to Veklury or any of its components; please see below for additional Important Safety Information for Veklury.
This approval is based on three randomized controlled trials including the recently published, final results of the National Institute of Allergy and Infectious Diseases’ (NIAID) double blind, placebo-controlled Phase 3 ACTT-1 trial, which showed that treatment with Veklury resulted in clinically meaningful improvements across multiple outcome assessments compared with placebo in hospitalized patients with COVID-19. Based on the strength of these data, Veklury has become a standard of care for the treatment of COVID-19 in hospitalized patients.
“The approval of Veklury marks an important milestone in efforts to help address the pandemic by offering an effective treatment that helps patients recover faster and, in turn, helps preserve scarce healthcare resources,” said Barry Zingman, MD, Professor of Medicine at the Albert Einstein College of Medicine and Montefiore Medical Center, New York. “The availability of a rigorously tested treatment that can significantly speed recovery and offers other benefits such as lower rates of progression to mechanical ventilation, provides hospitalized patients and their families important hope and offers healthcare providers a critical tool as they care for patients in need.”
“Since the beginning of the COVID-19 pandemic, Gilead has worked relentlessly to help find solutions to this global health crisis. It is incredible to be in the position today, less than one year since the earliest case reports of the disease now known as COVID-19, of having an FDA-approved treatment in the U.S. that is available for all appropriate patients in need,” said Daniel O’Day, Chairman and Chief Executive Officer, Gilead Sciences. “The speed and rigor with which Veklury has been developed and approved in the U.S. reflect the shared commitment of Gilead, government agencies and clinical trial investigators to advance well-tolerated, effective treatment options for the fight against COVID-19. We will continue to work at speed with the aim of enhancing patient outcomes with Veklury to ensure all patients with COVID-19 have the best chance at recovery.”
The incidence of adverse events associated with Veklury was similar to placebo in the ACTT-1 trial. Rates of serious adverse events (SAEs) were numerically higher in the placebo group compared with the Veklury group. Treatment discontinuation, all-cause grade 3 and 4 adverse events (AEs) and laboratory abnormalities were similar across groups. In the SIMPLE-Severe trial, the most common adverse reactions occurring in at least 5% of subjects in either the Veklury 5-day or 10-day group, respectively, were nausea (5% vs 3%), AST increased (3% vs 6%), and ALT increased (2% vs 7%). In the SIMPLE-Moderate trial, the most common adverse reaction occurring in at least 5% of subjects in the Veklury groups was nausea (7% in the 5-day group, 4% in the 10-day group).
To read the complete announcement, go here: https://www.gilead.com/news-and-press/press-room/press-releases/2020/10/us-food-and-drug-administration-approves-gileads-antiviral-veklury-remdesivir-for-treatment-of-covid19
Other treatments mentioned in a treatment “cocktail” that are showing success in addition to the remdesivir is dexamethasone, which is a steroid; anti-inflammatories and anti-coagulants, and regeneron, along with better ventilator management. Regeneron is still not in large enough production to handle the anticipated demand. The vitamin “cocktail” of Vitamin D and Zinc (and earlier, controversial mentions of the addition of hydroxychloroquine), are often mentioned both in a treatment protocol and a prevention plan. Other immune boosting lifestyle adjustments are getting enough sleep, eating well, getting sufficient exercise, and getting a flu shot.
Vaccines – at least 4 end-stage trials are in high gear, with good early results. Some select vaccines are already in use in other countries.
Earlier this week a physician from Johns Hopkins was interviewed on national news about vaccine production as well as treatment methods. Here is a portion of that interview where he notes the treatment methods coming on the forefront might be close to a “cure”: