Gilead Pauses Access To Experimental COVID-19 Drug Due To 'overwhelming Demand' Covid-19 Drug
A close up about a check supplies intended testing intended the coronavirus, Covid-19 is seen at Newton-Wellesley Hospital inside Newton, Massachusetts on top of March 18, 2020, as the hospital has set up three tents inside the parking garage where patients who own been pre-screened can show up intended testing.
Joseph Prezioso | AFP | Getty Images
Gilead Sciences has for the moment stopped granting patients access to remdesivir, its experimental drug on the novel coronavirus that causes COVID-19, citing "overwhelming demand," the company said Sunday.
The company said inside a statement that it is focused on top of processing previously approved requests, including that it is developing a new arrangement that it says drive approve patients to get the drug inside a similar time frame to what it would own taken to work through the requests it has received.
It drive make exceptions intended pregnant women including children under 18 years about age with confirmed COVID-19 including "severe manifestations" about the disease.
Remdesivir is being studied inside five great clinical trials, two about which could read out results inside early April. Up until now, Gilead has made it possible intended patients who want the drug to get it through a process called "compassionate use." To date, the company said, it has provided crisis access to several hundred patients inside the United States, Europe, including Japan.
The company said inside its statement that "enrollment inside clinical trials is the primary way to access remdesivir to create critical data that inform the appropriate use about this investigational medicine."
Some severely unwell patients, it acknowledges, drive be unable to enroll inside clinical trials including drive not own approved treatment options. For those, it is touching from a "compassionate use" arrangement to expanded access programs. It said the approach drive speed up access intended severely unwell patients including enable the company to collect data from all patients. These programs are under "rapid development" with regulators worldwide.
Gilead said that inside recent weeks there has been "an exponential increase" inside requests intended compassionate use because about the spread about the coronavirus inside Europe including the U.S. This has "flooded" its treatment access system, which was set up intended very limited access to the medicine including was, it said, "never intended intended use inside response to a pandemic."
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