Gilead Sciences has put a pause on administering the experimental antiviral drug remdesivir against the coronavirus that causes COVID-19 due to “overwhelming demand,” according to STAT News and a company statement.
Due to overwhelming demand, we are in the process of transitioning our compassionate access program to expanded access programs as rapidly as possible. Read more: https://t.co/YjK9ZkqWJo.— Gilead Sciences (@GileadSciences) March 22, 2020
The biopharmaceutical company released a statement saying that it will be focusing on processing approved requests and developing a new expanded access system that will allow patients to obtain remdesivir “in a similar expected timeframe that any new requests for compassionate use would have been processed.”
Patients who will still have access regardless of the temporary postponement include pregnant women and children under the age of 18 with “severe manifestations” of confirmed COVID-19 infections.
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Currently, the drug is reportedly being studied in five large clinical trials. Two of them are on track to potentially yield results in early April. Under a “compassionate use” mandate, Gilead was allowing patients who requested it to have access to remdesivir, although it isn’t proven to fight against the coronavirus.
Gilead has provided access to the drug to “several hundred patients” across the U.S., Japan and Europe. In its statement, the company acknowledged a recent “exponential” increase in requests for compassionate use in Europe and the U.S.
“We recognize that there are severely ill patients who are unable to enroll in clinical trials and for whom no approved treatment options are effective. Gilead has been working with regulatory agencies to provide remdesivir to these patients where feasible.”
Remdesiver was originally developed by Gilead to fight Ebola and Marburg viruses but has since shown promise against a range of other viruses, including coronavirus, SARS and MERS, as well as Lassa fever, Nipah virus, Hendra virus and others.
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