Gilead Stops Accepting Emergency Applications for Covid-19 Drug Remdesivir | Nasdaq

Published

Mar 22, 2020 6:29PM EDT

T he biotech company Gilead Sciences says it has received “overwhelming demand” for its experimental Covid-19 drug remdesivir in recent days would stop accepting emergency applications for it.

The biotech company says it received “overwhelming demand” for the drug in the past few days.

Gilead Sciences is no longer accepting requests for emergency access to the antiviral drug remdesivir, the experimental drug currently being tested as a treatment for patients suffering from Covid-19, the company said on Sunday.

In its statement, Gilead (ticker: GILD) said it had faced an “exponential increase” in so-called compassionate use requests for emergency access to the drug in recent weeks, and “overwhelming demand” in the past few days.

The company said that the emergency access system had been “flooded.” It said it would no longer accept new compassionate use requests, though it would make exceptions for pregnant women and children with “severe manifestations” of Covid-19.

It said it was setting up new expanded access programs to replace the emergency-use request system. Gilead said that the “primary way to access remdesivir” is through enrollment in clinical trials, but it understands that there are patients who cannot enroll in the trials.

“We recognize the urgent need and are working to implement the expanded access programs as quickly as possible, with the continued support and collaboration of regulatory agencies,” the company said.

Gilead has so far given emergency access to the drug to “several hundred patients” in the U.S., Europe, and Japan, the company said.

The company said it would process previously approved requests. It said that the new expanded access program would begin “in a similar expected time frame that any new requests for compassionate use would have been processed.”

The announcement was first reported by STAT, the health news website.

Shares of Gilead are up 20.9% so far this year. The S&P 500 is down 28.7% so far.

Write to Josh Nathan-Kazis at josh.nathan-kazis@barrons.com

The views and opinions expressed herein are the views and opinions of the author and do not necessarily reflect those of Nasdaq, Inc.

Gilead Stops Accepting Emergency Applications for Covid-19 Drug Remdesivir | Nasdaq

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