Almost two weeks after the FDA granted an Emergency Use Authorization for the experimental drug remdesivir for use in patients hospitalized with COVID-19, HHS has given an update on the supply and distribution.
The pharmaceutical company that developed remdesivir is donating 607,000 vials of the drug to the US government over a six-week period as part of its commitment to supply 1.5 million vials worldwide. While distribution is being handled by a commercial drug distributor, decisions regarding which hospitals get the drug have been left to government authorities. The drug is an infusion and will not be given to retail and specialty pharmacies.
The original round of distributions of the drug went to Indiana (38 cases), Massachusetts (117 cases), New Jersey (94 cases), New York (565 cases), Rhode Island (30 cases), Tennessee (seven cases) and Virginia (33 cases). Each case contains 40 vials of remdesivir.
HHS said that beginning May 7, several states would receive cases of the drug, including Connecticut (30 cases), Illinois (140 cases), Iowa (10 cases), Maryland (30 cases), Michigan (40 cases) and New Jersey (110 cases). State health departments will decide how to dole out the doses, according to HHS.
As of May 11, HHS is requesting weekly updates from hospitals to help inform the distribution of remdesivir. The first deadline was May 12. HHS is looking for data on the number of hospitalized COVID-19 patients, those suspected of having been infected, the number of patients on ventilators, and those currently in the ICU. HHS is tracking that information via its portal, TeleTracking, which it used to distribute emergency funds from the CARES Act.
Remdesivir’s manufacturer has been increasing its manufacturing capacity. The company said it aims to have 140,000 treatment courses available by the end of May, 500,000 courses by October and 1 million by December. Those manufacturing numbers are based on a 10-day treatment course.
“We are building a geographically diverse consortium of pharmaceutical and chemical manufacturing companies to help us meet and exceed these production goals by expanding capacity for raw materials and production beyond what any company could do individually,” the company said in a statement.
Ongoing clinical studies are testing a five-day course of remdesivir treatment, which could expand the number of patients that could receive the drug if proven safe and effective. The company is also looking into inhaled and oral doses of remdesivir that would allow it to be administered outside the hospital setting.
On Monday, the European Medicines Agency recommended expanding the compassionate use of remdesivir to patients who are not on mechanical ventilation. It is also recommending a five-day treatment course for patients not on ventilators. Patients who do not show improvement with the shorter course will continue with the full 10-day course. The recommendations are based on a study conducted by the National Institutes of Health in the US.
After study results showed that remdesivir could offer promise in shortening the time to recovery for patients hospitalized by COVID-19, hospitals across the country began clamoring for the drug. While the FDA’s EUA granted that access, it didn’t make clear how the supply was going to be allocated.