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The antiviral, which is awaiting regulatory approval as a coronavirus treatment, is one of a number of drugs in the spotlight as the U.S. scrambles to contain the pandemic. Remdesivir is being used in a number of clinical trials across the globe.
“Over the course of the past week, Gilead has been working in consultation with regulatory authorities to establish additional expanded access programs for remdesivir, our investigational medicine for COVID-19,” said Gilead CEO Daniel O’Day, in an open letter sent April 4. “The programs enable hospitals or physicians to apply for emergency use of remdesivir for multiple severely ill patients at a time. These are patients who cannot take part in clinical trials and where the word ‘emergency’ is all too real for them, their families and the health care providers advocating on their behalf.”
As America grapples with a growing number of coronavirus cases, demand for experimental drugs such as remdesivir has spiked. The family of Michael Goldsmith, a 34-year-old father of two on life support after being diagnosed with COVID-19, recently made a desperate plea to get him the experimental drug treatment.
Goldsmith’s family and the medical community also launched a campaign calling on President Trump to cut through the red tape and help make remdesivir available for patients who need it.
In his letter, O’Day acknowledged the pain experienced by families seeking treatment. “We know from the heartbreaking letters we receive, the images we see in the news and the all-too-bleak statistics that the urgency to find broad, effective solutions becomes more intense each day,” O’Day wrote. “In the ways we believe it is appropriate for Gilead to play a role today -- primarily through clinical trials, as well as expanded access and compassionate use -- we are doing everything it takes to meet our significant responsibility with remdesivir.”
Last week, Gilead told Fox News that it cannot comment on individual patient cases.
Goldsmith’s family told Fox News that his doctors say that he is now too far into his illness to benefit from remdesivir. However, his wife Elana told Fox News that he has been stable for a few days and is now receiving treatment with actemra, a rheumatoid arthritis drug that was recently approved by the FDA for COVID-19 clinical trials.
Gilead’s open letter on Saturday, Elana said, “is due to our efforts to make remdesivir for all who need it so we really made a difference.”
“I know [Michael] would be so happy that we have been able to help many people and families even though he couldn’t benefit from it himself,” she added.
Last month, Gilead announced changes to its treatment program. The company implemented an “expanded access” program in an effort to enable hospitals and physicians to apply for emergency use of remdesivir for multiple severely ill patients at a time. The prior “compassionate use” program is now designated for children and pregnant women.
Drug trials to treat coronavirus patients have garnered massive attention in recent weeks, although experts have warned that people should not take drugs unless prescribed by a doctor.
In a press conference last month, President Trump and FDA Commissioner Dr. Stephen Hahn described several approaches under testing, such as chloroquine, a drug long used to treat malaria, and remdesivir.
In his letter, O’Day said that Gilead has been ramping up remdesivir production, a process that requires specialized chemistry and multiple chain reactions. “It also calls for scarce raw materials as well as sterile manufacturing capabilities with limited global capacity, which are needed to make finished vials ready for administration to patients,” he said. “Working within these parameters, our teams have found multiple ways of accelerating production. These include process improvements that cut production times.”
As a result, Gilead has reduced its end-to-end manufacturing timeline from approximately a year to around six months. “In the space of two months, we have significantly increased our available supply of remdesivir using the inventory of active pharmaceutical ingredients we already had on hand,” O’Day said. “Our existing supply, including finished product ready for distribution as well as investigational medicine in the final stages of production, amounts to 1.5 million individual doses. Depending on the optimal duration of treatment, which is something we are studying in clinical trials, this supply could equate to well over 140,000 treatment courses for patients.”
“Gilead is providing the entirety of this existing supply at no cost, to treat patients with the most severe symptoms of COVID-19,” he added. “The 1.5 million individual doses are available for compassionate use, expanded access and clinical trials and will be donated for broader distribution following any potential future regulatory authorizations. These doses are for treating patients with severe symptoms, through daily intravenous infusions in a hospital setting.”
O’Day said that thousands of patients with COVID-19 are already involved in remdesivir clinical trials across the globe.
Over the coming months, the company plans to increase its supplies of remdesivir as raw materials with long lead times become available for manufacture. “We have set an ambitious goal of producing more than 500,000 treatment courses by October and more than 1 million treatment courses by the end of this year,” O’Day said.
As of early April 6, at least 1,288,372 coronavirus cases have been diagnosed worldwide, at least 337,933 of which are in the U.S. The disease has accounted for at least 70,482 deaths around the world, including at least 9,600 people in the U.S.
The Associated Press contributed to this article. Follow James Rogers on Twitter @jamesjrogers