Gilead pauses access to experimental COVID-19 drug due to ‘overwhelming demand’

Fitness

A close up of a test kit for testing for the coronavirus, Covid-19 is seen at Newton-Wellesley Hospital in Newton, Massachusetts on March 18, 2020, as the hospital has set up three tents in 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 in a statement that it is focused on processing previously approved requests, and that it is developing a new system that it says will allow patients to get the drug in a similar time frame to what it would have taken to work through the requests it has received.

It will make exceptions for pregnant women and children under 18 years of age with confirmed COVID-19 and “severe manifestations” of the disease.

Remdesivir is being studied in five large clinical trials, two of which could read out results in early April. Up until now, Gilead has made it possible for patients who want the drug to get it through a process called “compassionate use.” To date, the company said, it has provided emergency access to several hundred patients in the United States, Europe, and Japan.

The company said in its statement that “enrollment in clinical trials is the primary way to access remdesivir to generate critical data that inform the appropriate use of this investigational medicine.”

Some severely ill patients, it acknowledges, will be unable to enroll in clinical trials and will not have approved treatment options. For those, it is moving from a “compassionate use” system to expanded access programs. It said the approach will speed up access for severely ill patients and enable the company to collect data from all patients. These programs are under “rapid development” with regulators worldwide.

Gilead said that in recent weeks there has been “an exponential increase” in requests for compassionate use because of the spread of the coronavirus in Europe and the U.S. This has “flooded” its treatment access system, which was set up for very limited access to the medicine and was, it said, “never intended for use in response to a pandemic.”

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