Gilead Pauses Access To Experimental COVID-19 Drug Due To 'overwhelming Demand' Covid-19 Drug
A close up about a test kit for trying for the coronavirus, Covid-19 is seen at Newton-Wellesley Hospital within Newton, Massachusetts on March 18, 2020, while the hospital has set up three tents within the parking garage where patients who have been pre-screened can show up for testing.
Joseph Prezioso | AFP | Getty Images
Gilead Sciences has temporarily stopped granting patients access to remdesivir, its experimental drug against the novel coronavirus that causes COVID-19, citing "overwhelming demand," the company said Sunday.
The company said within a declaration that it is focused on processing before approved requests, including that it is developing a new system that it says drive allow patients to grow the drug within a similar time frame to what it would have taken to work through the requests it has received.
It drive make exceptions for pregnant women including children below 18 years about years accompanied by long-established COVID-19 including "severe manifestations" about the disease.
Remdesivir is being studied within five large unemotional trials, two about which could read away results within early April. Up until now, Gilead has made it possible for patients who want the drug to grow it through a process called "compassionate use." To date, the company said, it has provided emergency access to several hundred patients within the United States, Europe, including Japan.
The company said within its declaration that "enrollment within unemotional trials is the primary way to access remdesivir to generate critical data that inform the appropriate utilize about this investigational medicine."
Some severely ill patients, it acknowledges, drive be unable to enroll within unemotional trials including drive not have approved medical care options. For those, it is moving from a "compassionate use" system to expanded access programs. It said the approach drive speed up access for severely ill patients including enable the company to gather data from all patients. These programs are below "rapid development" accompanied by regulators worldwide.
Gilead said that within recent weeks there has been "an exponential increase" within requests for compassionate utilize since about the spread about the coronavirus within Europe including the U.S. This has "flooded" its medical care access system, which was set up for very limited access to the drug including was, it said, "never intended for utilize within response to a pandemic."
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