The World Health Organization (WHO) advises against using Remdesivir under any circumstances. Apparently, a prominent group of intensive care doctors in Europe feel the same way. The global health organization suggests, based on the results of the Solidarity Trial, that even in severe COVID-19 cases there is no evidence the antiviral drug improves survival or reduces the need for ventilation. Based on a large multi-center, multinational randomized, controlled trial, WHO’s Guideline Development Group (GDG) panel said its recommendation was based on an evidence derived on what turned out to be four global clinical trials involving the participation of over 7,000 patients hospitalized with SARS-CoV-2, the virus behind COVID-19. This is in sharp distinction specifically to the United States, where TrialSite has chronicled the drug’s developer, Gilead, has received a helping hand at critical steps along the way to U.S. Food and Drug Administration (FDA) approval. Gilead has generated at least $1 billion based on the sales of the antiviral drug thus far.
Another Setback for the Drug
As reported by Kate Kelland writing for Reuters, this recent declaration represents a material setback for Gilead that already has other shareholder pressures based on a depressed stock price. Priced as of this writing at 60.63 Gilead has been able to secure about $1 billion in revenue from the drug targeting COVID-19. Apparently, now Gilead is reducing its 2020 revenue forecast as demand, at least in some parts of the world where the WHO has influence, may wane.
Gilead Questions Results
Of course Gilead’s position is to question the results of the Solidarity Trial. Gilead recently declared in a corporate statement, “Veklury is recognized as a standard of care for the treatment of hospitalized patients with COVID-19 in guidelines from numerous credible national organizations.” Veklury is the trade name for remdesivir.
The statement continued, “We are disappointed the WHO guidelines appear to ignore this evidence at a time when cases are dramatically increasing around the world and doctors are relying on Veklury as the first and only approved antiviral treatment for patients with COVID-19.”
Their decision was based on the results experienced in several thousands of patients in strategically important randomized controlled trials. Watched by many, how could this decision not have some merit?
Its about Value
Increasingly drug producers will win or lose based on the true value their product brings to the market. This should be especially the case in a global pandemic where companies take federal subsidies and contributions for studies or where federal research agencies sponsor studies, hence socializing the costs of clinical development to the taxpayer.
The benefits to the therapy must be clear, argues WHO, based on a combination of ease of access (the drug is given intravenously and cumbersome to access) and cost not to mention safety and efficacy. At over $3,000 per dose, WHO suggests the value just isn’t’ there. As TrialSite has shared on numerous occasions, Gilead seemingly received a helping hand from federal research agencies and even regulators during its path to U.S. Food and Drug Administration (FDA) approval. For example, during a pivotal Phase 3 trial in the U.S., the sponsor, the National Institute of Allergy and Infectious Diseases (NIAID), literally changed the primary outcomes measures to be able to show any efficacy. An unorthodox practice that raised considerable eyebrows including the principals of this digital media platform.
Gilead hasn’t been able to demonstrate that the drug has any reduction on death rates or for that matter any other material outcomes for patients suggests WHO.
Real World Indicators?
TrialSite did report on a number of situations in the pandemic where the drug appeared to be useful in the clinic. In a few cases, patients saw significant turnaround upon administration of this medication in the acute setting. Hence, TrialSite does take the position that in the real world there are anecdotal cases of the drug appearing to evidence benefit. And during the NIAID-sponsored study the federal agency sponsor was able to demonstrate that the antiviral drug reduced the duration of illness by four days.
Although WHO’s guidelines are not binding they most certainly will over time impact remdesivir sales in the COVID-19 market. Part of what are called “living guidelines,” shares Reuters’ Ms. Kelland, WHO was preceded by a guidelines body sponsored by top intensive care doctors who advocate that remdesivir shouldn’t be used for COVID-19 patients cared for in critical care departments.
In that case, the European Society of Intensive Care Medicine (ESICM) recently declared that “remdesivir is now classified as a drug you should not use routinely in COVID-19 patient.” This statement was issued by Jozef Kesecioglu, President of ESICM.
WHO and other living guidelines are subject to change as more scientific medical data materializes.