Update: May 1, 2020
Following the announcement of positive results from two clinical trials of Gilead’s experimental drug remdesivir for COVID-19, the drug has now received emergency-use authorization from the US FDA for use in hospitalized patients with severe cases of the viral infection.
The emergency approval comes just two days after early results from clinical trials conducted by Gilead and the NIAID at the National Health Institute (NIH) that studied the use of remdesivir in critically ill COVID-19 patients were announced. The results from the trials showed that the drug improved clinical outcome and could shorten the time to recovery. It must be noted that the results were modest and thus further study with more patients, as well as testing in milder cases is warranted to gain a clearer picture of the drug’s efficacy.
With this announcement, remdesivir now becomes the first authorized treatment for COVID-19 in the US.
“This is an important clinical advance that showed a statistically significant reduction in time to recovery for patients with COVID-19 and is the first authorized therapy for COVID-19,” said FDA Commissioner Stephen Hahn said on Friday.
According to Gilead and CNN, the “FDA has limited its authorization of the drug to adults and children with suspected or laboratory-confirmed COVID-19, particularly severe disease, which includes low blood oxygen levels, the need for oxygen therapy or the need for a ventilator or other intensive breathing support.”
The drug must be administered intravenously and while the optimal dosing remains unknown, Gilead recommends that patients on ventilators take the drug for ten days and non-ventilator patients for five days.
Gilead has announced that it will donate 1.5 million doses of the drug worldwide with plans to accelerate production of more doses. This will cover 140,000 patients based on a 10-day treatment cycle. Gilead has not revealed what it will charge for the medication after the supply of donated doses are used up.
Original story published April 30, 2020:
Remdesivir may be getting closer to gaining approval as a treatment for COVID-19 after showing encouraging results in clinical trials.
The US Food and Drug Administration (FDA) may issue an emergency-use authorization for the drug, according to reports from The New York Times. This is certainly good news as there are currently no drugs approved for the treatment of COVID-19.
In a press release on Wednesday, Gilead Sciences, Inc., maker of remdesivir, announced early findings from its open-label Phase III SIMPLE trial of its experimental antiviral drug remdesivir for COVID-19, citing that it can shorten recovery times in severely ill COVID-19 patients and lead to overall improvements in clinical outcome.
Gilead reported that the time to clinical improvement for 50 percent of patients in the trial was 10 days in the 5-day treatment group versus 11 days in the 10-day treatment group. In addition, they stated that on Day 14 (the day on which clinical status was assessed as a trial endpoint), “64.5 percent of patients in the 5-day treatment group and 53.8 percent of patients in the 10-day treatment group achieved clinical recovery.”
It also seems that early treatment led to better outcomes as patients in the study who received remdesivir within ten days of having symptoms exhibited improved outcomes compared with those treated after more than ten days of symptoms appearing.
Gilead also acknowledged positive preliminary results reported from another COVID-19 remdesivir trial conducted by the National Institute of Allergy and Infectious Diseases (NIAID), which is a part of the National Institutes of Health (NIH). The study found that remdesivir can improve recovery from COVID-19 by up to 31 percent.
The results from these trials were highly awaited as remdesivir has been positioned to be a promising candidate among several potential treatments currently being tested for COVID-19. It is also one of the drugs being tested in the World Health Organization’s (WHO) SOLIDARITY megatrial.
Remdesivir is a nucleotide analogue (more specifically, an adenosine analogue), which inserts into viral RNA during replication, thereby interfering with the virus’ ability to make copies of itself in host cells.
Remdesivir was initially developed by Gilead against other coronaviruses (such as the ones that cause SARS and MERS) and was later tested in Ebola, but showed poor results for it in clinical trials. It has now been repurposed as a potential treatment for COVID-19.
Preliminary results from the NIAID trial found that patients who received remdesivir had a 31 percent quicker recovery time than patients who received placebo. The trial, called the Adaptive COVID-19 Treatment Trial (ACTT), is a randomized-control trial involving 1,063 COVID-19 patients that began on February 21.
The trial found the median time to recovery was 11 days for remdesivir-treated patients compared with 15 days for patients on placebo control. There was also a survival benefit as the mortality rate for the patient group that received remdesivir was 8.0 percent, compared with 11.6 percent for the placebo group. The trial is especially significant because it is one of the first placebo-controlled studies for remdesivir.
On the other hand, results from a remdesivir COVID-19 trial conducted in China were published in the journal Lancet recently, which reported that remdesivir failed to improve the condition of patients or decrease the presence of the virus in the bloodstream. In an earlier statement on the study, Gilead commented that the findings, which were released prematurely by WHO last week, were “inconclusive because the study was terminated early.”
Dr. Anthony Fauci, White House coronavirus disease task force member and infectious disease expert, is very hopeful of the promise that the drug holds as a potential COVID-19 treatment. In speaking to reporters in the Oval Office at the White House on Wednesday, Dr. Fauci said, “the data shows that remdesivir has a clear cut significant positive effect in diminishing the time to recover. This is really quite important.”
He did add caution though, addressing concerns that further studies will be needed to fully assess its efficacy and safety. However, he went on to say that “although a 31 percent improvement doesn’t seem like a knockout hundred percent, it’s a very important proof of concept. Because what it has proven is that a drug can block this virus.”
Dr. Fauci predicts that, “this will be the standard of care,” for COVID-19.
In a statement to CNN, FDA spokesman Michael Felberbaum said, “as part of the FDA’s commitment to expediting the development and availability of potential COVID-19 treatments, the agency has been engaged in … discussions with Gilead Sciences regarding making remdesivir available to patients as quickly as possible, as appropriate.”
Fast-tracked regulatory approvals for demonstrated, effective COVID-19 treatments are highly warranted as the number of COVID-19 cases continues to grow in the US, with new waves of the infection now expected in countries across the world.