The US food and drug regulatory body has allowed emergency use of an investigational anti-viral vaccine to treat COVID-19 patients after some research programmes, including one led by an Indian-American physician, found that the drug helped some of the infected cases recover faster.
The Food and Drug Administration (FDA) gave emergency use authorisation (EUA) for the use of investigational anti-viral remdesivir in the treatment of COVID-19 patients.
The FDA authorisation came after research programmes, including one led by Indian-American physician Aruna Subramanian, reported remdesivir shortened the recovery times in people who have fallen ill from the new coronavirus.
“I'm pleased to announce that Gilead now has a EUA (emergency use authorisation) from the FDA for remdesivir,” US President Donald Trump told reporters at the White House on Friday.
Trump said that EUA is an important treatment for hospitalised coronavirus patients.
Health and Human Services Secretary Alex Azar said that this is a significant step forward in battling COVID-19.
The EUA allows for remdesivir to be distributed in the US and administered intravenously by health care providers, as appropriate, to treat suspected or laboratory-confirmed COVID-19 in adults and children hospitalised with severe conditions.
By Friday, over 63,000 Americans have died of the coronavirus and over one million have tested positive with COVID-19.
Trump said that his administration has been doing work with the teams at the FDA, National Institute of Health and Gilead for spearheading this public-private partnership to make this happen very quickly.
“I think this really illustrates what can happen in such a short time. For the first case, that was diagnosed in the United States to now, our first step forward with a therapeutic in less than 90 days,” said Deborah Birx, a member of the White House Task Force on Coronavirus.
In a statement, Gilead said that the EUA will facilitate broader use of remdesivir to treat hospitalised patients with severe COVID-19 disease, enabling access to the vaccine at additional hospitals across the country.
Remdesivir is authorised for the treatment of hospitalised patients with severe COVID-19 disease, it said, adding that the optimal duration of treatment is still being studied in ongoing clinical trials.
Under the EUA, both five-day and 10-day treatment durations are suggested, based on the severity of the disease. The authorisation is temporary and does not take the place of the formal new drug application submission, review and approval process, Gilead noted.
“This EUA opens the way for us to provide emergency use of remdesivir to more patients with severe symptoms of COVID-19,” said Daniel O’Day, chairman and chief executive officer of Gilead Sciences.
“We will continue to work with partners across the globe to increase our supply of remdesivir while advancing our ongoing clinical trials to supplement our understanding of the drug's profile. We are working to meet the needs of patients, their families and healthcare workers around the world with the greatest sense of urgency and responsibility,” he said.
According to Gilead, the EUA is based on available data from two global clinical trials—the National Institute for Allergy and Infectious Diseases’ placebo-controlled Phase 3 study in patients with moderate-to-severe symptoms of COVID-19, including those who were critically ill, and Gilead's global Phase 3 study evaluating 5-day and 10-day dosing durations of remdesivir in patients with severe disease.
Multiple additional clinical trials are ongoing to generate more data on the safety and efficacy of the drug as a treatment for COVID-19, it said.
Earlier in an interview to Fox News, Subramanian said that “there's a lot more work to be done in terms of exactly who should get this drug, what is the best timing, who is at highest risk for having complications … And what can we add to this or what can we improve upon this to make outcomes even better.”
“This (remdesivir) is a direct-acting antiviral. It has been shown to have great promise in the lab and in animal models and for the first time now in human clinical trials,” Subramanian told Fox News.
“We know that so far, it's been very safe and tolerable. We've had good clinical outcomes and yesterday we found that compared to placebo, that is people who are given no medication, people do much better,” she said.
FDA Commissioner Stephen M. Hahn said, “today's action is an important step in our efforts to collaborate with innovators and researchers to provide sick patients timely access to new therapies where appropriate, while at the same time supporting research to further evaluate whether they are safe and effective.”