With hospitals seeing an overwhelming number of COVID patients, the FDA has approved the use of the antiviral drug remdesivir on an outpatient basis giving doctors a new option in treating mild-to-moderate COVID cases. Continue reading “FDA Approves Anti-Viral Drug For Outpatient COVID Treatment”
Gilead Sciences Inc. has announced that it will charge U.S. hospitals approximately $3,120 for the majority of patients who need remdesivir, one of the first drugs to show significant upside in treating COVID-19.
From Bloomberg News:
Patients suffering from the illness caused by the novel coronavirus are usually given six vials of remdesivir over five days. The price, which comes to $520 a vial, would apply to commercially insured patients in the U.S., according to a letter from Gilead Chief Executive Officer Daniel O’Day posted on the company’s website Monday.
It plans charge $390 a vial, or $2,340 for a five-day regimen, for direct government purchases by the U.S. or other developed countries.
Gilead’s pricing decision is consequential because it sets a precedent for how much future Covid-19 treatments might cost. While it’s higher than some patient groups had pushed for, it was close to a level that some drug-pricing watchdogs have said would be acceptable based on remdesivir’s expected benefit.
Gilead has promised to donate 940,000 doses of the medication through the month of June. So far, nearly a quarter of a million treatment courses of remdesivir have been made available for free.
The New York Times reports the F.D.A. is expected to authorize as early as Wednesday Gilead Sciences’ experimental anti-viral drug remdesivir for emergency use in treating patients with Covid-19.
Dr. Anthony S. Fauci, the federal government’s leading infectious diseases scientist, told reporters a trial study overseen by the National Institutes of Health showed clear signs the drug could make a difference in speeding up the recovery of some patients.
Dr. Fauci said the federal trial indicated that the drug remdesivir could shorten the time to recovery by about a third. “Although a 31 percent improvement doesn’t seem like a knockout 100 percent, it is a very important proof of concept because what it has proven is that a drug can block this virus,” Dr. Fauci said. “This is very optimistic.”
In a statement, Gilead Sciences said it was “aware of positive data emerging from” the study by Dr. Fauci’s institute, known as NIAID. “We understand that the trial has met its primary endpoint and that NIAID will provide detailed information at an upcoming briefing.”
Remdesivir is not yet licensed or approved in the United States or anywhere in the world “and has not yet been demonstrated to be safe or effective for the treatment of Covid-19,” according to Gilead.
Remdesivir has never been approved as a treatment for any disease. It was developed to fight Ebola, but results from a clinical trial in Africa were disappointing.
For some weeks now, Donald Trump has heralded malaria drug hydroxychloroquine as showing “tremendous promise” to combat COVID-19 but no study has yielded any sufficient data (yet) that bears out Trump’s “feeling” that it would be the salvation folks are hoping for.
But drugmaker Gilead may have some good news soon about its experimental drug Remdesivir.
Remdesivir was one of the first medicines identified as having the potential to impact SARS-CoV-2, the novel coronavirus that causes COVID-19, in lab tests. The entire world has been waiting for results from Gilead’s clinical trials, and positive results would likely lead to fast approvals by the Food and Drug Administration and other regulatory agencies.
If safe and effective, it could become the first approved treatment against the disease.
The University of Chicago Medicine recruited 125 people with COVID-19 into Gilead’s two Phase 3 clinical trials. Of those people, 113 had severe disease. All the patients have been treated with daily infusions of remdesivir.
“The best news is that most of our patients have already been discharged, which is great. We’ve only had two patients perish,” said Kathleen Mullane, the University of Chicago infectious disease specialist overseeing the remdesivir studies for the hospital.
It’s important to note that a group of 125 patients in Chicago isn’t large enough to give researchers the depth of information they need.
Gilead is currently overseeing 152 separate clinical trials around the world involving 2,400 severe patients. There are an additional 169 trials following 1,600 moderate COVID-19 patients. Until the trials are closed and the numbers crunched we won’t have a clear idea as to how useful the drug might be against coronavirus.
That said, one man’s story definitely shows promise.
Slawomir Michalak, a 57-year-old factory worker from a suburb west of Chicago, told StatNews he went to the University of Chicago Medicine hospital on Friday, April 3, when he spiked a 104 fever and found it difficult to breathe.
He was put on oxygen and given the option to join the severe coronavirus trial.
On Saturday, April 4, he received his first infusion of the drug. “My fever dropped almost immediately and I started to feel better,” he said.
The next day, he received a second dose and was able to breathe without supplemental oxygen. After two more daily treatments of remdesivir, he was well enough to be discharged on Tuesday, April 7.
It’s only one man’s experience with the drug, but let’s keep our fingers crossed.