Gilead made a remarkable request of the FDA in regard to its coronavirus drug

March 25, 2020, 10:48 PM UTC

Happy Wednesday, readers.

Remdesivir, the experimental COVID-19 treatment from Gilead, has been one of the drugs thought to have the most potential to treat the novel coronavirus. It’s already been deployed in the U.S. and multiple other countries as this pandemic spreads.

During, say, any other time in the history of the biotech industry, that’s an advantage a corporation would likely hold onto. Clearly, these aren’t normal times. More on that in a second.

Under Food and Drug Administration (FDA) guidelines, therapies that haven’t been officially approved can still be used to treat sick patients on an emergency or “compassionate use” basis, especially for those with the highest risk of death.

That was the case for remdesivir until earlier this week when the rapidly-growing number of COVID-19 patients pushed demand so far that it exceeded how much Gilead could produce, and the company said it had to stop supplying it.

But then came another twist—the FDA granted remdesivir an “orphan drug” designation.

This is some nuanced stuff, but in essence: it’s a designation usually given for experimental drugs that treat rare disorders (which are defined as diseases which affect 200,000 people or less). But there are some weird exceptions.

For instance, even if a disease is new and thought likely to eventually affect a much bigger swath of the population than 200,000 people, a company can still get an orphan drug designation. (Spoiler alert: More than 200,000 people will probably be affected by coronavirus.)

Such a designation, if Gilead were to use it, would be a financial boon to the firm, granting all sorts of advantages, like seven years of market exclusivity and major tax credits.

But Gilead made a voluntary request to pull the designation. It’s a remarkable move for the company.

“Gilead recognizes the urgent public health needs posed by the COVID-19 pandemic. The company is working to advance the development of remdesivir as quickly as possible, and will provide updates as they become available,” the company said in a statement.

I’m following up with Gilead to figure out the thinking behind all of this. The biotech’s statement emphasized that it was confident remdesivir would speed its way to the market regardless of whether or not it had such a designation. But I don’t think I’ve ever seen this happen before. My guess is the firm wouldn’t want to be blamed for what would seem like a profiteering move during a crisis—still, it’s pretty intriguing.

Read on for the day’s news.

Sy Mukherjee


A band of health IT giants get in on the COVID-19 fight. Companies ranging from electronic health record (EHR) vendors such as Epic and Athenahealth are teaming up with the likes of Microsoft, Amazon Web Services, and major health systems such as the Mayo Clinic and Intermountain Healthcare (among multiple other organizations) to tackle coronavirus. The firms describe it as "a collaborative industry response to the novel coronavirus" aimed at aggregating all sorts of data—including available hospital beds and bottlenecks for respirators, clinical data about how the virus spreads, and host of other information.


Vir Biotechnology plans to advance its own COVID-19 treatments. Vir Biotechnology, a startup headed up by former Biogen chief George Scangos (who has also been enlisted to lead the biotech industry's coronavirus efforts by the sector's largest trade group) announced on Wednesday that it has identified several potential drug candidates to treat COVID-19. What makes Vir's approach interesting is that it relies on "monoclonal antibodies" (for a more precise definition of exactly what those are, and why they're so important in medicine, I'd encourage you to re-visit my feature about Humira). "Stopping this disease will take a combination of prevention and treatment approaches," said Scangos in a statement. What he means is that a mix of antivirals, antibodies, and other therapies will be critical to stemming the tide of this disease as firms work on a lasting vaccine.


The federal government is ramping up Medicaid waivers in the wake of coronavirus. It's no secret that the U.S. health system is fragmented. So in a time of public health crisis, it shouldn't come as much of a surprise that such a system presents a lot of uncertainty during a global pandemic—especially for the poorest people in the country. That may require ad hoc responses. As ModernHealthcare reports, the Centers for Medicare & Medicaid Services (CMS) have granted seven more states (Indiana, Iowa, Kansas, Kentucky, Missouri, Oregon, and Rhode Island) waivers that would allow Medicaid beneficiaries to seek care at facilities not traditionally authorized to accept those on Medicaid. It goes to show how an influx of COVID-19 patients could very well overwhelm the health system. (ModernHealthcare)


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