Following three successful clinical trials, Veklury (remdesivir) is now available for hospital purchase directly from its distributor, Gilead Sciences, ending the government’s distribution role.
The move follows five months during which the U.S. government managed allocation and distribution of the drug’s limited supply to COVID-19 patients. As a result, approximately 150,000 treatment courses of donated Veklury were provided, and more than 500,000 treatment courses were produced, according to Health and Human Services Secretary Alex Azar.
It has been authorized for emergency use by the Food and Drug Administration (FDA). Still, at the beginning of this month, the FDA removed the U.S. government’s directing role from that authorization and gave sole authority back to Gilead and its authorized distributors. Despite the change, the U.S. government does not expect the price to change or for hospitals to pay more than the $3,200 wholesale acquisition price per treatment.
“Now, federal government oversight of the allocation of Veklury is not required because the drug is no longer a scarce resource—a tribute to progress we have made against COVID-19 and to the strength of our partnerships with the private sector,” Azar said.
This, according to the HHS, is due to Veklury supplies exceeding market demand. Only 160,981 uses of Veklury were purchased by hospitals in state jurisdictions, of the 423,765 samples requested by states. Going forward, Gilead expects to produce sufficient quantities of Veklury to meet needs and demands. To date, it has also donated 1.5 million vials of the drug and provided clinical supply at no cost for evaluation and investigational trials worldwide.
AmerisourceBergen will remain the sole U.S. distributor of Veklury until the year’s end. That is an effort to maintain consistency in the distribution process. All sales will be direct to hospitals.