In the eight months since the Gilead Sciences antiviral drug remdesivir became the first FDA-approved treatment for Covid-19, the company has been collecting real-world data about drug’s effect. The data continue to show that the drug reduces the risk of death and helps patients get discharged from the hospital sooner.
While the White House and doctors at Walter Reed have sought to reassure the public that Trump's condition is improving, he has received numerous drugs for Covid-19, including the steroid dexamethasone, which is typically administered only to those who are critically ill.
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The company said it was meeting real-time supply demands for Veklury (remdesivir) in the U.S. and anticipated meeting global demands for the drug worldwide. AmerisourceBergen will continue acting as sole U.S. distributor.
An analyst wrote Wednesday that the combination of Lilly's Olumiant and Gilead's Veklury, or remdesivir, could cost nearly $8,000, a high price tag that could potentially hamper uptake, especially given the availability of cheaper drugs like dexamethasone.
In a commentary, physicians and pharmacists wrote that percentages of Black, Latino and Native American patients in two Phase III studies of the drug that the company is using for FDA approval were disproportionate to Covid-19's incidence in those communities.
Gilead Sciences had said in its second-quarter earnings that it would partner with companies in North America, Europe and Asia to manufacture the antiviral drug, which received an emergency use authorization from the FDA in May.
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A successful cocktail would also serve us in the long-run to treat the impacts of Covid-19 and keep those who are most vulnerable, the elderly and those with pre-existing conditions, more resilient against serious illness or death.
The study is enrolling 60 healthy volunteers aged 18-45, but the company hopes it will form the basis of trials of the drug as an outpatient treatment for patients who do not require hospitalization. Remdesivir is currently administered via IV.
HHS said it had acquired all the supplies of the drug for July and 90% of supplies for August and September. Many developing countries have access to generic versions, but WTO rules could complicate the ability of wealthy nations to import them.
The company determined a price of $520 per vial for U.S. payers and $390 for government payers outside the U.S., the latter price being designed to avoid the need for country-by-country pricing negotiations, CEO Daniel O'Day wrote in an open letter.
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In an open letter, Gilead CEO Daniel O'Day wrote that the company plans to start screening participants for the Phase I study program starting this week. The biotech company also plans to test intravenous remdesivir in outpatient settings.
Topline results from the company's Phase III trial showed a statistically significant improvement in the time patients took to recover after getting the drug for five days, but data for the 10-day regimen did not reach statistical significance despite also showing an improvement.
The Phase III study of Actemra with remdesivir is expected to start enrolling toward its target of 450 patients in June, with data being reported this summer.
The arrangement is analogous to the emergency use authorization that the drug received from the FDA earlier this month. Peer-reviewed data from the Phase III NIAID study of the drug were published Friday.
The authors wrote that the data highlight the need to identify and start Covid-19 patients on antiviral therapy before they progress to requiring mechanical ventilation. The data were published in The New England Journal of Medicine.