The Federal Department of Health and Human Services announced this week that the federal government has purchased more than 500,000 treatment courses of the drug remdesivir, for use in the U.S. This is almost the maker Gilead Science’s entire production for July, August, and September.
The FDA (Food and Drug Administration) on May 1 approved use of the drug for severely ill COVID-19 patients, just days after Dr. Anthony Fauci, head of the National Institute of Allergy and Infectious Diseases, said preliminary results of a placebo-controlled, randomized trial with remdesivir were showing positive results in treating COVID-19.
Time to recovery –release from the hospital– was 11 days compared to the control group of 15 days. Dr. Fauci said this may not sound like much, but this is an important proof of concept that shows that a drug can block this virus.
The mortality rate in the study trended towards being better, ie fewer deaths, 8% vs 11% in the placebo group.
Remdesivir is one of only two drugs currently shown to effectively treat severely ill COVID-19 patients, the other being dexamethasone, a steroid that’s been in use for other purposes for years.
The HHS purchase of 500,000 doses represents 100 percent of Gilead’s projected production for July, 90 percent of production in August and 90 percent of production in September, in addition to an allocation for clinical trials. A treatment course of remdesivir is, on average, 6.25 vials.
Numerous publications have pointed out that the action of the U.S. has shut out all other countries, or made it more difficult for them to obtain remdesivir for treating COVID-19 patients. EuroWatch says the European Union, as a result of the actions of the U.S., is currently talking with Gilead about the company’s ability to increase its production capacity. Right now, remdesivir is the only drug approved by the European Medicines Agency (EMA) to treat patients with the novel coronavirus.
“President Trump has struck an amazing deal to ensure Americans have access to the first authorized therapeutic for COVID-19,” said HHS Secretary Alex Azar.
The environmental and public policy watchdog publication Ecowatch noted that the same day HHS made the announcement, Gilead announced it is pricing the drug at just over $3,000 a treatment. Ecowatch said Peter Maybarduk, director of Public Citizen’s Access to Medicines Program, “slammed the Trump administration for failing to ensure that the price of a drug developed with substantial taxpayer support is affordable for all.” Maybarduk said Federal grants already provided around $70 Million for development of the drug and it could be priced lower and still provide a profit for Gilead.
For more about the HHS actions and their plan to distribute remdesivir to hospitals, click here.